CDSCO risk classification
Obstetrical and Gynecological medical device classification
Every obstetrical and gynecological device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 47 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 199
- Class A
- 59
- Class B
- 100
- Class C
- 37
- Class D
- 2
Obstetrical and Gynecological devices and their class
199 devices
Abdominal decompression chamber
Obstetrical and Gynecological
Class CNon- invasive medical device placed at abdomen to alleviate abdominal pain during pregnancy or delivery.
Abdominal decompression chamber pump
Obstetrical and Gynecological
Class CA dedicated pump used with hood-like device to control and reduce abdominal pressure of a pregnant women.
Abortion suction system manual aspirator
Obstetrical and Gynecological
Class BA non-sterile, manual, syringe-like device to aspirate fluid from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation. Also used for endometrial biopsy.
Amniotic membrane perforator, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA surgical instrument used to rupture the amniotic membrane to assist in childbirth, without causing injury to the mother or foetus
Amniotic Membrane Perforator, single-use
Obstetrical and Gynecological
Class BA sterile, hand-held, manual surgical instrument intended to rupture the amniotic membrane to assist in childbirth, without causing injury to the mother or foetus. It may also be referred to as an amniotomy hook or an amniotome. This is a sterile, single-use device.
Amniotome, reusable
Obstetrical and Gynecological
Class BA surgical instrument used to rupture the amniotic membrane to assist in childbirth, without causing injury to the mother or foetus
Anti-shock body support/Garment
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA non-invasive device intended to prevent excessive blood loss and prevent post partum haemorrhage complications.
Applicator for Fallopian Tube Ligation Ring, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA surgically-invasive, manually-operated device intended to load tubal rings for their introduction and application to the fallopian tubes for the purpose of fallopian tube ligation/occlusion. This is a transient-use, reusable device intended to be sterilized prior to use.
Applicator for Fallopian Tube Ligation Ring, single-use
Obstetrical and Gynecological
Class BA surgically-invasive, mechanical device intended to load tubal rings for their introduction and application to the fallopian tubes for the purpose of fallopian tube ligation/occlusion. This is a single-use device.
Assisted Reproduction (IVF) Procedure Dish
Obstetrical and Gynecological
Class BA container intended exclusively for manipulation, storage, preparation and culturing of human gametes or embryos for use in assisted reproduction techniques (ART), including in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other IVF procedures used in assisted reproduction clinics. This is not intended for general-purpose laboratory use for cell culture or microbiological work. This is a sterile, single-use device.
Bartholin Gland Catheter
Obstetrical and Gynecological
Class BCatheter is used for the treatment of abscesses and cysts of the Bartholin gland.
Birthing bed/table, non- powered
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA manually-operated, adjustable device intended to support a pregnant woman's body in an appropriate position during labour and delivery, and may in addition be intended for other obstetrical examination or treatment procedures. This device may be referred to as a birthing/obstetric bed, table, couch, or chair. This does not include any diagnostic/therapeutic device or instrument.
Birthing bed/table, powered
Obstetrical and Gynecological
Class ANon-sterile, non-measuringBed used during labor and delivery.
Birthing cushion
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA device intended to provide positional support and comfort for a pregnant woman during labour and/or childbirth. It may be placed on the floor and might facilitate a variety of birthing positions. This is a reusable device.
Bladder-supporting pessary
Obstetrical and Gynecological
Class Binserted into the vagina to facilitate management of female urinary incontinence and/or to reduce bladder prolapse.
Breast pump support kit, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA collection of non-sterile items (e.g., breast shields, tubing, connectors, milk collection containers , etc.) intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. This is a reusable device.
Breast transilluminator
Obstetrical and Gynecological
Class CActive device transmitted through the female breast to visualize translucent tissue for the diagnosis of cancer, or other conditions, diseases or abnormalities.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Calibrated Obstetric Drape, single-use
Obstetrical and Gynecological
Class AA sterile device, designed as a sheet with a pouch with calibrated graduation markings, intended to be placed beneath a parturient woman (i.e., in labour) for the postpartum collection of blood and objective measurement of blood loss (by gravity) as an aid in detection of postpartum hemorrhage. It is only intended for use in vaginal births and may not be used in caesarean/non-vaginal or assisted surgical births. It is a single-use device.
Cardiotocograph
Obstetrical and Gynecological
Class CA device that records fetal heart rate and uterine contraction simultaneously.
Cardiotocograph transducer
Obstetrical and Gynecological
Class CA device that converts birthing contractions to electrical signals and is used together with cardiotocograph (CTG) which displays the signals.
Cardiotocography telemetric monitoring system
Obstetrical and Gynecological
Class CAn assembly of devices intended to be used to continuously measure and wirelessly transmit foetal heart rate and uterine contraction signals from a patient to a monitor.
Cardiotocography telemetric monitoring system receiver
Obstetrical and Gynecological
Class CA part of wireless telemeter system. It receives signals from transmitter that senses fetal heart rate and uterine contraction during labor.
Cardiotocography telemetric monitoring system transmitter
Obstetrical and Gynecological
Class CIt transmits signals related to fetal heart rate and uterine contractions to the receiver.
Catheter-tip transducer, pressure
Obstetrical and Gynecological
Class BA device intended to be incorporated into the distal end of a catheter (not included) to measure pressure.
Cervical anaesthesia kit
Obstetrical and Gynecological
Class BFor providing intercervical nerve block during gynaecological diagnostic tests such as dilation and curettage, small excisional procedures such as endometrial biopsy, or for pain management during labour and/or delivery. This is a single-use device.
Cervical anaesthesia needle, reusable or single use
Obstetrical and Gynecological
Class BA sharp bevel-edged, hollow tubular metal instrument intended to be used to administer anaesthetic agent to function as an intracervical nerve-block.
Cervical cytology scraper, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringIntended to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. It does not have any additional functional uses.
Chorionic Villus Sampling Catheter
Obstetrical and Gynecological
Class BAn ultrasound guides a thin catheter through the cervix to your placenta.The chorionic villi cells are gently suctioned into the catheter.
Colposcope
Obstetrical and Gynecological
Class BSpecial microscope for examination of female genital organs (e.g., vagina, cervix).
Contraceptive cervical cap, reusable or single use
Obstetrical and Gynecological
Class CDevice inserted into the cervix to prevent semen from entering the uterus.
Contraceptive spermicide
Obstetrical and Gynecological
Class CA chemical substance (e.g., nonoxynol-9) intended to be introduced with an applicator or the finger into the vagina before sexual intercourse, to destroy sperm (spermatozoa) to prevent pregnancy.
Contraceptive sponge
Obstetrical and Gynecological
Class CBubble like device works as a physical barrier to prevent spermatic invasion into uterus.
Cu-T
Obstetrical and Gynecological
Class DIndicated for intrauterine contraception for up to 10 years
Diaphragm pessary
Obstetrical and Gynecological
Class CA circular device placed in the vagina prior to intercourse to mechanically prevent conception.
Disposable Kelly pad
Obstetrical and Gynecological
Class ANon-sterile, non-measuringIntended to funnel blood to a collection device in order to help detect postpartum hemorrhage. It does not have measuring function.
Douche kit
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA packaged collection of non-sterile items (douche solution prefilled in a douche unit) intended to provide cleansing of the vaginal area.
Electric Breast Pump
Obstetrical and Gynecological
Class BAn electrically powered, non-invasive suction unit intended for use by lactating mothers for expression of breast milk for collection and storage, to enable infant feeding when direct breastfeeding is not possible (e.g., in case of congenital conditions or hospitalization, etc.) and support continued lactation. It may be used as an aid in relieving engorged breasts or plugged milk ducts by supporting continued milk flow, or mothers with breastfeeding difficulties such as mastitis, latch problems, or poor milk transfer, etc. It may consist of collection bottle, tubings, and other non-invasive accessories.
Elevator, uterine
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA hand held surgical instrument that is intended to be inserted into the uterus to manually lift and manipulate this structure during gynecological surgery. This is a reusable device.
Endocervical aspirator
Obstetrical and Gynecological
Class BA collection of devices designed to remove superficial tissue from the mucous membrane lining the cervical canal (endometrium) through manually-powered suction.
Endocervical specimen collection kit, no additive
Obstetrical and Gynecological
Class BSterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the endocervix for culture, analysis, and/or other investigation
Endometrial biopsy curette, reusable
Obstetrical and Gynecological
Class BSurgical instrument used for the removal of small amounts of endometrial secretions and/or tissue from the uterus for biopsy purposes.
Endometrial biopsy curette, single use/disposable
Obstetrical and Gynecological
Class BEndometrial biopsy kit
Obstetrical and Gynecological
Class BFor the collection of a tissue sample taken from the lining of the uterus (endometrium).
Endometrial cytology brush
Obstetrical and Gynecological
Class BA brush used to collect mucosal cell for pathological diagnosis during endoscopic examination.
Endoscope Sheath, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA non-powered endoscope accessory intended to provide access to an endoscope (e.g., cystoscope, hysteroscope, etc.) and other instruments for endoscopic procedures. It may act as a protective barrier to isolate the endoscope from patient contact and allow irrigation of the examination field. This is a transient-use, reusable device. This is supplied non-sterile.
Fallopian tube biopsy everting-balloon catheter
Obstetrical and Gynecological
Class BA sterile device intended to be inserted through a hysteroscope to obtain biopsy samples from a fallopian tube for cytological examination.
Fallopian tube catheterization kit
Obstetrical and Gynecological
Class BA collection of sterile devices for the trans uterine catheterization of the fallopian tubes to inject dye or contrast medium for the evaluation of tubal patency.
Fallopian tube insufflator
Obstetrical and Gynecological
Class BActive invasive device designed to insufflate the Fallopian tubes with a gas [typically carbon dioxide (CO2)] to maintain tubal patency for a procedure.
Fallopian tube occlusion insert
Obstetrical and Gynecological
Class DContraceptive implantable device implanted into the uterine end of the fallopian tubes to function as a contraceptive by obstructing the natural fallopian tube passage.
Fallopian tube prosthesis
Obstetrical and Gynecological
Class CA device designed to maintain the patency (openness) of the fallopian tube and is used after reconstructive surgery.
Feeding nipple
Obstetrical and Gynecological
Class ANon-sterile, non-measuringIntended for use as a feeding nipple for infants with oral or facial abnormalities.
Fibreoptic vaginal speculum
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA hand-held manual instrument intended to dilate and illuminate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It does not have any additional features/intended purposes and cannot connect to high-risk active devices. This is a reusable device.
Filter for gas central supply system
Obstetrical and Gynecological
Class ANon-sterile, non-measuringIntended to remove particulates and volatile organic compounds (VOCs) from the gas flowing into incubators used in IVF procedures.
Fixed-diameter cervical dilator, reusable
Obstetrical and Gynecological
Class BTo dilate the cervical canal with balloon when uterine does not dilate enough due to inertia uteri.
Fixed-diameter cervical dilator, single use/disposable
Obstetrical and Gynecological
Class BFlexible fibreoptic culdoscope
Obstetrical and Gynecological
Class BFlexible endoscope for visual examination, diagnosis, and treatment of urinary bladder and urethra.
Flexible fibreoptic hysteroscope
Obstetrical and Gynecological
Class BFor the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus).
Flexible fibreoptic laparoscope
Obstetrical and Gynecological
Class BFor the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs
Flexible fibreoptic mammary ductoscope
Obstetrical and Gynecological
Class BFor the visual examination and treatment of the mammary duct.
Flexible fibreoptic salpingoscope
Obstetrical and Gynecological
Class BFor the visual examination and treatment of the fallopian tubes (oviducts).
Flexible ultrasound laparoscope
Obstetrical and Gynecological
Class BFor the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs.
Flexible video culdoscope
Obstetrical and Gynecological
Class BFor the visual examination and treatment of the female peritoneal cavity and organs.
Flexible video hysteroscope
Obstetrical and Gynecological
Class BFor the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus).
Flexible video laparoscope
Obstetrical and Gynecological
Class BFor the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs.
Flexible video mammary ductoscope
Obstetrical and Gynecological
Class BFor the visual examination and treatment of the mammary duct.
Flexible video salpingoscope
Obstetrical and Gynecological
Class BFor the visual examination and treatment of the fallopian tubes (oviducts).
Foetal acoustic stimulator
Obstetrical and Gynecological
Class BUses sound stimuli to assess foetal well-being. This device is used to evaluate the status of the foetus as expressed by, e.g., foetal heart rate changes or foetal acid-base status, in antepartum tests and/or during intrapartum monitoring.
Foetal bladder shunt
Obstetrical and Gynecological
Class CA sterile non-bioabsorbable tubular device implanted in the bladder of a foetus with post-vesicular obstructive uropathy, to decompress the urinary tract for urine to pass from bladder into the amniotic sac, until the defect can be surgically repaired after birth
Foetal blood sampler
Obstetrical and Gynecological
Class BInvasive device to collect fetal blood through uterine cervix.
Foetal cardiac monitor
Obstetrical and Gynecological
Class CActive device designed to detect, measure, and display foetal heart activity during the perinatal period
Foetal Doppler system
Obstetrical and Gynecological
Class CActive non-invasive device to detect foetal heart beats using ultrasound/Doppler technology.
Foetal Doppler system probe
Obstetrical and Gynecological
Class CPlaced on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology.
Foetal pleuro-amniotic catheter
Obstetrical and Gynecological
Class CSterile implantable device used to continuously drain fetal pleural effusion to maternal amniotic cavity.
Foetal scalp electrode, clip
Obstetrical and Gynecological
Class CPlaced directly on the scalp of the fetus in the uterus to monitor fetal vital signs.
Foetal stethoscope
Obstetrical and Gynecological
Class AMechanical hearing device used to listen to fetal heartbeat.
Foetal vacuum extraction cup, reusable or single use
Obstetrical and Gynecological
Class BA device used to extract the head of the fetus with a vacuum cup.
Foetal vacuum extraction system monitor
Obstetrical and Gynecological
Class BA battery-powered vacuum measuring device that is connected via tubing to the suction line of a foetal vacuum extracting cup, to measure and record data related to a vacuum-assisted delivery such as level of vacuum applied, the number and duration of pulls, and number of pop-offs.
Foetal vacuum extraction system, manual, reusable or single use
Obstetrical and Gynecological
Class BTo facilitate the delivery of a foetus during vaginal childbirth or Caesarean.
Foetal vacuum extraction system, pneumatic
Obstetrical and Gynecological
Class BTo facilitate the delivery of a foetus during vaginal childbirth or Caesarean.
Foetal/maternal multiple physiological parameter simulation kit
Obstetrical and Gynecological
Class BTo imitate a variety of physiological parameters and conditions (both foetal and maternal) expressed during pregnancy in order to test and calibrate foetal and patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers.
Foetal/maternal multiple physiological parameter simulator
Obstetrical and Gynecological
Class BTo imitate a variety of physiological parameters and conditions (both foetal and maternal) expressed during pregnancy in order to test and calibrate foetal and patient monitoring and recording equipment, check patient cable continuity, or train healthcare providers.
Forceps, gynaecological/Gynaecologic al grasping forceps, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to be used for the general grasping, pulling, or compression of internal structures during a gynaecological surgical intervention they are not intended for laparoscopic use. This is a transient- use, reusable device intended to be sterilized prior to use.
Forceps, obstetric, general- purpose, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA scissors-like obstetrical instrument intended specifically to assist the birth of the foetus during difficult vaginal births. This is a reusable device.
Gamete and embryo retrieval, storage and transfer medium
Obstetrical and Gynecological
Class CUsed in Assisted reproductive procedure which includes retrieval, culture, transport,storage, handling, and transfer of human gametes and embryos by creating a physiological environment. It may include buffer solution and medicinal substance like Gentamicin, etc.
Gynaecological bib
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA piece of cloth worn by the patient.
Gynaecological biopsy forceps, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to obtain biopsy specimens from gynaecological tumours or other gynaecological tissues for histopathological examination. This is a reusable device. It is not intended to be connected to an active device.
Gynaecological Cerclage Needle
Obstetrical and Gynecological
Class BIt is a loop like instrument used to suture the cervix.
Gynaecological examination/treatment table
Obstetrical and Gynecological
Class ANon-sterile, non-measuringTo support a woman's body in the appropriate positions during gynaecological examinations.
Gynaecological operating table top
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA component of a modular operating table designed as a detachable table top constructed for gynaecological surgical procedures.
Gynaecological operating table, electrohydraulic or electromechanical or hydraulic
Obstetrical and Gynecological
Class ANon-sterile, non-measuringActive device designed to support a patient during gynaecological surgical procedures.
Gynaecological polypectomy forceps
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended for the transvaginal removal of polyps from the vagina and uterus. This is a reusable device. This is not intended to be connected to an active device and intended for transient use.
Gynaecological scissors, reusable
Obstetrical and Gynecological
Class not statedTo cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use.
The class is missing from CDSCO's register data for this entry. Check the CDSCO register before relying on it.
Gynaecological scissors, single use/disposable
Obstetrical and Gynecological
Class BGynaecological surgical microscope
Obstetrical and Gynecological
Class ANon-sterile, non-measuringTo improve visualization of anatomical structures via transmitted light during gynaecological surgery (e.g., on the fallopian tubes).
Gynecological couch (examination table)
Obstetrical and Gynecological
Class ANon-sterile, non-measuringTo support a woman's body in the appropriate positions during gynaecological examinations.
Gynecological Laser System Handpiece
Obstetrical and Gynecological
Class CA dedicated device, consisting of an optical fiber, handpiece and other accessories, intended for use in conjunction with a medical diode laser system [not included], for application of thermal energy to vaginal mucosal membrane and external genitalia to improve blood circulation and tissue remodelling. This is used for the purposes of treating vaginal dryness, laxity, postmenopausal tissue changes, etc.
Handling medium
Obstetrical and Gynecological
Class CIntended for use in Assited reproductive procedure which involves manipulation of gametes or embryos. Specially, it is indicated for use as an oocyte retrival medium during ovarian follicle aspiration procedure, washing sperm prior to IVF and ICSI (Intra Cytoplasmic sperm injection) fertilization procedures, and for transport of the embryo to the utreus during embryo transfer procedure. It may include medicinal and protein supplements like Gentamicin, Human Serum Albumin (HSA), etc.
Heel stirrup
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA device used during a medical/surgical procedure to steadily hold a patients foot (feet) by cradling the heel or the whole foot.
Hook, intrauterine device removal
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA hand-held manual instrument intended to be used by a physician for the extraction of an intrauterine device (IUD). This is a reusable device.
Hook, surgical, gynaecological, fibroid
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to fix or apply traction to uterine fibroids. This is a transient-use, reusable device intended for be sterilized prior to use.
Hyaluronidase solution
Obstetrical and Gynecological
Class CIntended for use in removing cumulus cells surrounding oocytes (denudation) in preparation for ICSI (Intra cytoplasmic sperm injection) or other Assisted reproductive procedures. It is a enzymatic solution containing of bovine derived hyaluronidase in a HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid) buffered HTF (Human Tubal Fluid) medium supplemented with therapeutic grade human serum albumin and gentamicin sulfate.
Hysterosalpingography (HSG) Catheter, single use
Obstetrical and Gynecological
Class AA sterile tube intended for delivery of contrast medium or/and saline into the uterine cavity/fallopian tubes to facilitate hysterosalpingography, or enhance saline infusion hysterosonography. It may include devices dedicated to catheter function (e.g., stylet, syringe). It does not connect to high-risk active medical devices. This is a single-use device.
Hysteroscopic insufflator
Obstetrical and Gynecological
Class BA device that sends the gas into the fallopian tube to maintain the patency of the tubes.
Hysteroscopic irrigation/insufflation system
Obstetrical and Gynecological
Class BUsed during endoscopic procedures of the uterus to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization and enlarge the surgical field. It also circulates the fluid to provide irrigation that will remove tissue/debris from the site.
Hysteroscopy Operative Sheath, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA non-powered device intended for use in hysteroscopy procedures to allow endoscopic instruments [e.g., hysteroscope, etc.] to be inserted into the uterus for diagnosis or treatment. This is a transient-use, reusable device.
Hysteroscopy Set
Obstetrical and Gynecological
Class BA collection of devices, consisting of a hysteroscope, and manual endoscopic instruments such as sheaths/adapters, endoscopic scissors, endoscopic forceps, etc., intended for the direct visualization, investigation, diagnosis of gynecological conditions, and manipulation and removal of uterine fibroids, polyps, or adhesions from the uterine cavity. This does not include electrosurgical devices. This may be a reusable/single-use device.
In Vitro embryo culture medium, through day 3 of development
Obstetrical and Gynecological
Class CThis medium is intended for use in assisted reproductive procedures which include human gamete and embryo manipulation. It is used as a culture medium through day 3 of development. It may be used as a stand-alone medium, or as the first stage of a sequential medium protocol. It may include medicinal substance like Gentamicin, etc.
In Vitro embryo Culture medium, through day 5/6 of development
Obstetrical and Gynecological
Class CIt is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. It is used as a culture medium for human gametes and embryos from fertilization through day 5/6 of development. It may include medicinal substance like Gentamicin and protein supplement like Human serum Albumin (HSA), etc.
In-Vitro Fertilization/Embryo Transfer Catheter
Obstetrical and Gynecological
Class BA cellular transfer catheter is provided for implantation of cellular material into the uterus of a patient.
Intrauterine cannula, reusable
Obstetrical and Gynecological
Class BTo aspirate fluid/material from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation it may also be intended for endometrial biopsy.
Intrauterine cannula, single use/disposable
Obstetrical and Gynecological
Class BIntrauterine Device (IUD) Insertion Kit, single-use
Obstetrical and Gynecological
Class AA collection of sterile, non-powered, hand-held instruments, including medication applicator forceps, uterine tenaculum, uterine sound and IUD thread cutting scissors, intended to manipulate the uterine cavity and IUD to enable the insertion of the IUD in the uterine cavity. This does not contain any medications or surgically invasive devices. This is a single-use device intended for transient-use only.
Intrauterine Device Thread Extractor (Retriever)
Obstetrical and Gynecological
Class AA non-powered, transient-use device intended to locate and extract the threads of an intrauterine device (IUD) through the endocervical canal and from within the uterine cavity. This is not a surgically-invasive device, and does not connect to any high-risk active devices. It may also be subsequently used to extract the IUD. The device is supplied sterile and intended for single-use.
Intrauterine haemostatic balloon catheter
Obstetrical and Gynecological
Class BA sterile, flexible tube with an inflatable balloon inserted into the uterus and distended with a medium (e.g., sterile water, medical air or other appropriate gas) to reduce postpartum bleeding with pressure.
Intrauterine haemostatic suction catheter
Obstetrical and Gynecological
Class BInserted into the uterus to reduce postpartum bleeding through aspiration of blood/debris and induction of uterine contractions.
Intrauterine imaging medium catheter
Obstetrical and Gynecological
Class BIntrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus.
Intrauterine imaging medium catheterization kit
Obstetrical and Gynecological
Class BSterile devices intended for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus.
Laparoscope laser adaptor
Obstetrical and Gynecological
Class ANon-sterile, non-measuringLaparoscope laser coupler
Obstetrical and Gynecological
Class BTo connect the laparoscope to the laser or the laser arm for laparoscopic laser treatment.
Laparoscope system
Obstetrical and Gynecological
Class BFor the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy).
Laparoscope system, reusable or single use
Obstetrical and Gynecological
Class BFor the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy).
Laparoscopic surgery handle
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA manually operated handle of various configurations intended to hold instruments used in laparoscopic surgery. This is a reusable device.
Male/Female Condoms
Obstetrical and Gynecological
Class CCondom with nonoxynol-9, micro-condom, prophylactic (condom) – latex sheath, non-latex, condoms with natural membrane, intravaginal condoms etc.
Manual expandable cervical dilator
Obstetrical and Gynecological
Class BTo dilate the cervical canal with balloon when uterine does not dilate enough due to inertia uteri.
Maternity belt
Obstetrical and Gynecological
Class ANon-sterile, non-measuringIt is used to support the belly bump during the different prenatal periods to avoid forward and downwards stomach pulling, provide maximum support and relieve back & pelvic ache.
Maternity pad
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA specially-designed, externally worn, absobent pad to absorb postpartum bleeding and vaginal discharge that occurs after childbirth (lochia). This is a single-use device.
Mechanical foetal heart simulator
Obstetrical and Gynecological
Class BTo imitate a foetal heart (e.g., foetal heart ultrasound signals) when used in combination with a foetal/maternal multiple physiological parameter simulator in order to test foetal monitoring and recording equipment [e.g., cardiotocograph (CTG)], check patient cable continuity, or to train healthcare providers.
Menstrual Cup
Obstetrical and Gynecological
Class BPlaced in the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses.
Motorized laparoscopic forceps
Obstetrical and Gynecological
Class BActive surgical instrument designed for grasping, mobilizing, and suturing tissues/vessels under direct or endoscopic visualization during a surgical procedure.
Myoma Screw, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA non-sterile, hand-held, manual instrument intended to extract fibroids from the endometrium during myomectomy. It may be inserted through another device (e.g., laparoscope, hysteroscope, trocar) or used during open surgery. It does not connect to any high-risk active medical device. This is a transient-use, reusable device intended to be sterilized prior to use.
Nipple pad/ring, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA device intended to be worn directly over the breast/nipple of a nursing woman between breast feedings to help protect the nipple from chafing, due to friction from clothing, and/or to treat sore/cracked nipples it may also be intended to absorb leaking breast milk.
Oil for embryo culture
Obstetrical and Gynecological
Class BIt is used as an overlay to cover small volumes of culture media during human embryo and gamete manipulation to prevent evaporation of culture media.
Oocyte Aspiration Needle
Obstetrical and Gynecological
Class BMission to collect the maximum amount of undamaged oocytes in a short time as possible.
Panniculus skin-adhesive retractor, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringThis retractor is intended to be used on intact skin for positioning redundant tissue (i.e., post c- section, post laparotomy) away from the lower abdominal incision/wound.
Papanicolaou smear kit or Endometrial sampling kit
Obstetrical and Gynecological
Class BUsed to collect and prepare pap smears samples in a medical institute.
Pelvic examination kit
Obstetrical and Gynecological
Class BFor performing pelvic examination
Pelvimeter
Obstetrical and Gynecological
Class BA measuring device used to determine the pelvic dimensions.
Pelviscope
Obstetrical and Gynecological
Class BAn endoscope used for visual examination and diagnosis of pelvis.
Perineal warmer
Obstetrical and Gynecological
Class Bit is useful for pain relief in the vulva after episiotomy.
Perineometer
Obstetrical and Gynecological
Class BTo determine perineal muscle strength through resistance to spontaneous contraction of perineal muscle. Also used to diagnose and treat urinary incontinence and sexual dysfunction through movement.
Polyvinylpyrrolidone (PVP) Solution
Obstetrical and Gynecological
Class CUsed in Assisted reproductive procedure which include human gamete and embryo manipulation. It uses PVP solution for immobilizing sperm for ICSI (Intra cytoplasmic sperm injection) procedures.This solution may include protein supplement like Human Serum Albumin (HSA), etc.
Postpartum maternity belt
Obstetrical and Gynecological
Class ANon-sterile, non-measuringIt is intended to help reduce swelling, provide support to the lower back and abdominal muscles, and promote healing after delivery.
Preservation medium for human semen
Obstetrical and Gynecological
Class CIt is intended for cryopreservation of human semen for later use in Assisted Reproductive procedure. It may include medicinal and biological components like glycerol, gentamicin, Test Yolk Buffer (TYB),etc.
Protein supplement for in vitro embryo culture
Obstetrical and Gynecological
Class BFor use in assisted reproductive procedures which include gamete and embryo manipulation, as a supplement for culture media. It may include protein supplement like Human Serum Albumin (HSA), Synthetic Serum Substitute (SSS), Dextran Serum Supplement (DSS), etc. Not for use as an injectable product.
Pudendal anaesthesia kit
Obstetrical and Gynecological
Class BA collection of sterile devices designed to deliver anaesthetic agent to the external genitalia of humans.
Resectoscope
Obstetrical and Gynecological
Class BAn endoscope used for visual examination, diagnosis and treatment, especially for resection of tissues.
Rigid culdoscope
Obstetrical and Gynecological
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the female peritoneal cavity and organs.
Rigid fibreoptic hysteroscope
Obstetrical and Gynecological
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus).
Rigid mammary ductoscope
Obstetrical and Gynecological
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the mammary duct.
Rigid optical laparoscope
Obstetrical and Gynecological
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs.
Rigid salpingoscope
Obstetrical and Gynecological
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the fallopian tubes (oviducts).
Rigid ultrasound laparoscope
Obstetrical and Gynecological
Class BAn endoscope with a rigid inserted portion, combined with an ultrasound probe, intended for the visual examination, treatment, and ultrasonic imaging of the abdominal/retroperitoneal cavity and its organs.
Rigid video hysteroscope
Obstetrical and Gynecological
Class BActive device intended to allow visual examination and treatment of the canal of the cervix and the uterine cavity (uterus).
Rigid video laparoscope
Obstetrical and Gynecological
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs.
Salpingography Catheter
Obstetrical and Gynecological
Class BUsed for injection of contrast medium into the fallopian tube(s) for selective salpingography.
Scissors, gynaecological, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to cut tissues during a gynaecological surgical procedure it is not intended for obstetric use. This is a reusable device for transient use.
Scissors, umbilical cord, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended specifically to cut the umbilical cord after birth. This is a transient-use, reusable device.
Sexual Lubricant
Obstetrical and Gynecological
Class BA non-sterile substance (e.g., gel) intended for topical penile/vaginal application for supplementing body's natural lubrication, preventing discomfort and/or vaginal dryness during sexual intercourse. This is not intended for use on injured skin/tissue. This does not contain any pharmaceutical agents.
Skull plate anvil, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA non-powered surgical instrument intended to form alterable skull plates in the proper shape to fit the curvature of a patients skull. This is a reusable device.
Sperm cryopreservation medium
Obstetrical and Gynecological
Class CIt is intended for use in Assisted Reproductive procedure involving the cryopreservation and storage of semen.
Sperm processing media
Obstetrical and Gynecological
Class CDesigned to maintain sperm quality on the table top without CO2 incubation. This procedure includes use of this medium for sperm washing by supporting all steps of sperm preparation prior to fertilization. It may contains protien supplements like human serum albumin (HSA), bovine serum albumin, etc.
Sperm Separation Medium
Obstetrical and Gynecological
Class BIt is intended for separation of the motile fraction of sperm from seminal fluid. It works on the principle of isopycnic separation.
Suprapubic needle, surgical, reusable
Obstetrical and Gynecological
Class BPercutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair.
Suprapubic needle, surgical, single use/ disposable
Obstetrical and Gynecological
Class BTest Tube Warming Unit
Obstetrical and Gynecological
Class AA powered device intended for warming and maintaining the temperature of aspirated follicular fluid and gametes (oocytes, sperms) close to normal body temperature as an aid in maintaining their viability during assisted reproductive procedures. This is not a vitrification thawing kit or medium. This is a reusable device.
Tissue Expanders
Obstetrical and Gynecological
Class CIntended to be used in breast reconstruction or treatment of soft tissue deformities such as used following mastectomy or for treatment of underdeveloped breasts.
Transabdominal (Fetoscope) Amnioscope and accessories
Obstetrical and Gynecological
Class CIt is a device designed to permit direct visual examination of the foetus by a telescopic system via abdominal entry. The device is used to ascertain foetal abnormalities.
Transcervical (Amnioscope) Endoscope and accessories
Obstetrical and Gynecological
Class BIt is a device designed to permit direct viewing of the foetus and amniotic sac by means of an open tube introduced into the uterus through the cervix.
Tubal Rings/Fallopian Rings
Obstetrical and Gynecological
Class CContraception devices for female sterilization.
Umbilical cord clamp, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA non-sterile device intended for clamping the umbilical cord after birth. This is a reusable device.
Umbilical ligator
Obstetrical and Gynecological
Class ASurgical device used for umbilical cord ligation.
Umbilical ligator, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringIntended for umbilical cord ligation during surgical procedures. This is a reusable device intended for transient use.
Umbilical occlusion device
Obstetrical and Gynecological
Class AThese devices may be a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.
Uterine balloon therapy devices
Obstetrical and Gynecological
Class CSystem is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Uterine injector
Obstetrical and Gynecological
Class BUsed to inject liquid, drug, or other substance into uterus. It is a reusable device.
Uterine manipulator cervical cup/transilluminator
Obstetrical and Gynecological
Class BAllow manipulation of the uterus under suction whilst preventing laparoscopic insufflation gas from escaping from the cervix (during hysterectomy).
Uterine manipulator, reusable
Obstetrical and Gynecological
Class BSurgical instrument designed to mechanically manipulate the position of the uterus during a gynaecological intervention
Uterine manipulator, single use/disposable
Obstetrical and Gynecological
Class BUterine packer
Obstetrical and Gynecological
Class AA hand-held, surgical instrument used to introduce dressings into the uterus or vagina. This is a reusable device.
Uterine packer, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringIntended for introducing dressings into the uterus or vagina. This is a reusable device.
Uterine probe, reusable
Obstetrical and Gynecological
Class BFor exploring the uterus during a surgical procedure. Used as a component of a uterine manipulator
Uterine probe, single use/disposable
Obstetrical and Gynecological
Class BUterine Sound, single-use
Obstetrical and Gynecological
Class AA sterile, hand-held, manual device intended to measure and/or explore the internal depth or length of the uterus, cervix, and/or vagina and may aid in procedures such as hysterosalpingography, IUD placement/retrieval, etc. It typically possesses graduations of length displayed along its working end. It does not connect to any high-risk active medical devices. This is a single-use device.
Uterus-supporting pessary
Obstetrical and Gynecological
Class BInserted into the vagina to hold the uterus in place.
Vaginal applicator, non- sterile, single use
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA non-sterile, single use device intended to apply medication to the vagina.
Vaginal applicator, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringIntended to apply medication to the vagina. This is a reusable device.
Vaginal applicator, reusable or single use
Obstetrical and Gynecological
Class AA device designed to apply medication to the vagina.
Vaginal dilator, reusable
Obstetrical and Gynecological
Class BInserted into the vagina to dilate a narrow vaginal opening due to congenital defect. Can be used during examination, treatment or surgical procedure.
Vaginal dilator, single use/ disposable
Obstetrical and Gynecological
Class BVaginal douche, reusable or single use
Obstetrical and Gynecological
Class BTo deliver a liquid (usually solution) directly into the vaginal cavity for hygienic purpose as a douche.
Vaginal illuminator
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA device intended to illuminate the vagina during a gynaecological examination or procedure.
Vaginal speculum, reusable
Obstetrical and Gynecological
Class ANon-sterile, non-measuringA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It does not have any additional features/intended purposes and cannot connect to high-risk active devices. This is a reusable device.
Vaginal stent
Obstetrical and Gynecological
Class CA device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.
Vaginometer
Obstetrical and Gynecological
Class AA device that measures the length and diameter of vagina.
Vaginoscope
Obstetrical and Gynecological
Class BFor paediatric vaginal examination. To search foreign matter or bleeding site.
Viscera retention paddle or Visceral retainer
Obstetrical and Gynecological
Class BUsed to hold an organ at proper position (i.e., viscera) while the surgeon performs a suturing procedure (typically internal wound closure). It is also implanted into a surgical site temporarily.
Vitrification freezing kit
Obstetrical and Gynecological
Class CIt is intended for use in Assisted Reproductive procedure for vitrification and storage of human oocytes (MII), Pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. It may include medicinal and protein supplements like Gentamicin, Dextran Serum Supplement (DSS), etc.
Vitrification Thawing/Warming kit
Obstetrical and Gynecological
Class CIntended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos that have been vitrified using vitrification freeze kit.It may include medicinal and protein supplements like Gentamicin, Dextran Serum Supplement (DSS), etc.
Water for Assisted Reproductive Technologies
Obstetrical and Gynecological
Class BIntended for use in ART Laboratories procedure requiring a non- pyrogenic high quality pure grade of water.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
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