CDSCO risk classification
Neurological medical device classification
Every neurological device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 13 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 135
- Class A
- 26
- Class B
- 32
- Class C
- 37
- Class D
- 40
Neurological devices and their class
135 devices
Analgesic PENS system
Neurological
Class BIntended to deliver controlled electrical impulses directly to the subcutaneous tissue (i.e., invasively) in the vicinity of a peripheral nerve as relief of chronic neuropathic pain.
Analgesic TENS system
Neurological
Class BIntended to treat pain by transcutaneous electrical simulation on peripheral nerves.
Analytical non- scalp cutaneous electrode
Neurological
Class ANon-sterile, non-measuringElectrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring.
Analytical non- scalp cutaneous lead
Neurological
Class ANon-sterile, non-measuringIntended to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance].
Analytical scalp electrode
Neurological
Class BIntended to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device].
Analytical scalp lead
Neurological
Class BIntended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals during encephalography (EEG).
Aneurysm clip
Neurological
Class DAn aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting
Aneurysm Implant (detachable coils/clips)
Neurological
Class DIt is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Antiseizure/psych iatric-therapy vagus nerve electrical stimulation system
Neurological
Class DImplantable device intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression).
Atrial cerebrospinal fluid catheter
Neurological
Class DIntended to be implanted as the distal component of a ventriculoatrial shunt to channel cerebrospinal fluid (CSF) to the right atrium where it can be absorbed into the body.
Auditory Brainstem Implant System
Neurological
Class DAn auditory brain stem implant is a small device that is surgically implanted in the brain of a deaf person whose auditory nerves is lacking or damaged. The auditory nerves conduct the sound signals from the ear to the brain. The implant enables otherwise the deaf people to have a sensation of hearing.
Autonomic neuropathy heart rate meter
Neurological
Class CIntended to diagnose autonomic nervous system dysfunction (autonomic neuropathy).
Balloon for Cerebrovascular Occlusion
Neurological
Class DBalloon used to treat Blockage or closing of cerebrovascular vessels/carotid arteries.
Bare-metal intracranial vascular stent
Neurological
Class DIntended to be implanted into the base or parent artery of an intracranial aneurysm.
Behavioural therapy electrical stimulation system
Neurological
Class CIntended in the treatment of obsessive/compulsive behaviour and drug abuse, by applying electrical impulse(aversion therapy).
Biopsy Needle Kit
Neurological
Class BA set of neurosurgical instruments designed to allow multiple biopsies from one or more targets in one trajectory.
Bladder/bowel- evacuation implantable electrical stimulation system
Neurological
Class DIntended to empty the urinary bladder and/or the bowels by applying electrical stimuli typically to the cone-shaped end of the spinal cord (conus medularis).
Brain injury adjunctive interpretive electroencephalograph assessment aid
Neurological
Class CA brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patients electroencephalograph (EEG) to provide an interpretation of the structural condition of the patients brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.
Brain-responsive electrical stimulation system
Neurological
Class DIntended to continuously monitor brain activity and deliver electrical stimuli to seizure foci in response to neurological disorders (e.g., epilepsy).
Cardiac-therapy vagus nerve electrical stimulation system
Neurological
Class DIntended to apply periodic stimuli to the vagus nerve as a treatment for cardiac failure.
Central Nervous System Shunt including Neurological Catheters and other Components
Neurological
Class DIt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume.
Cerebral perfusion catheter
Neurological
Class DIntended for brain protection during profound hypothermic circulatory arrest during aortic surgery.
Cerebrospinal Catheter
Neurological
Class DFor treatment or prevention of cranial/spinal cerebrospinal fluid fistula.
Cerebrospinal fluid manometer
Neurological
Class CIntended to measure the cerebrospinal fluid (CSF) pressure/intracranial pressure via lumbar puncture.
Cerebrospinal fluid shunt valve programmer
Neurological
Class CIntended to noninvasively modify the operating pressure of a programmable, non-active, implanted cerebrospinal fluid (CSF) shunt valve that is part of a CSF shunt.
Coma-arousal vagus nerve electrical stimulation system
Neurological
Class DIntended to apply periodic stimuli to the vagus nerve for the purpose of exciting the patient to arousal from a vegetative state (i.e., a deep coma).
Conductive abrasive gel for skin preparation, non-sterile
Neurological
Class ANon-sterile, non-measuringNon-sterile conductive gel intended to reduce the resistance (impedance) and defatting the skin in preparation for electrophysiological examinations: electroencephalography (EEG), long-term EEG monitoring, polysomnography (PSG), evoked potentials (EP), stress test ECG, ECG monitoring by Holter in clinics, hospitals, diagnostic centers.
Conductive electrode gel/paste (adhesive/non- adhesive), non-sterile
Neurological
Class ANon-sterile, non-measuringA non-sterile gel intended to reduce resistance between skin and electrodes during examinations such as ECG, EEG, EMG, etc.
Cortical electrode
Neurological
Class DA cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity
Cranial bur
Neurological
Class AIntended to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue.
Cranial electrotherapy stimulator
Neurological
Class DA cranial electrotherapy stimulator is a device that applies electrical current to a patients head to treat insomnia, depression, or anxiety
Cranial perforator
Neurological
Class BMetallic rotary endpiece designed to cut a hole(s) or a circular section(s) of the skull vault (calvarium) by attaching to powered drill/handpiece.
Cranial trephine
Neurological
Class AIntende as a neurosurgical blade used to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior.
Cranial trephine, reusable
Neurological
Class ANon-sterile, non-measuringA manual neurosurgical blade intended to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior, for various purposes such as catheter insertion, injection of dyes, etc. It is an exchangeable device that may be specifically attached to a manually-rotated handle only. This is a reusable device, intended for transient use.
Craniotomy power tool system handpiece
Neurological
Class CIntended to be used to rotate a cranial cutting tool (i.e., a drill bit, bur, trephine or perforator) in order to produce a hole or holes in the skull vault (calvarium).
Cryogenic surgical device
Neurological
Class DA cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site
Cutaneous electrode
Neurological
Class BA cutaneous electrode is an electrode that is applied directly to a patients skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation
Deep brain electrical stimulation system
Neurological
Class DDesigned to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders, psychiatric disorders and/or to treat chronic, severe, intractable pain.
Deep brain electrical stimulation system lead
Neurological
Class CIntended to be implanted in specific areas of the deep brain and used along with deep brain electrical simulation system.
Depth electrode
Neurological
Class CA depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain
Diagnostic peripheral nerve electrical stimulation system
Neurological
Class CIntended to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region.
Diagnostic somatosensory tactile stimulation system
Neurological
Class BIntended to be used to apply tactile stimuli to the body (e.g., pneumatic activation of a membrane to the fingers and lips) typically for evoked response procedures to investigate the function and potential disorders of the brain.
Diskectomy system, percutaneous, automatic
Neurological
Class DIntended for the percutaneous (through the skin) removal of the nucleus pulposus from the lumbar disc.
Dura mater sealant
Neurological
Class CIntended to be applied to sutured dura mater to prevent cerebrospinal fluid (CSF) leakage during healing.
Dural Graft Implant
Neurological
Class CDural Graft Implant is intended for use in procedures where the repair or substitution of the patient’s dura mater is needed.
Echoencephalograph
Neurological
Class CAn echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head
Ejaculation electrical stimulation system
Neurological
Class CIntended to apply electrical stimuli to the nerves that control ejaculation.
Electroconvulsive therapy system
Neurological
Class CIntended to apply strong electrical stimuli to a patients brain to induce convulsions and loss of consciousness, typically to treat major depression, schizophrenia, or mania.
Electroencephalogram (EEG) signal spectrum analyzer
Neurological
Class BAn electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal
Electroencephalograph
Neurological
Class CAn electroencephalograph is a device used to measure and record the electrical activity of the patients brain obtained by placing two or more electrodes on the head.
Electroencephalograph electrode/lead tester
Neurological
Class BAn electroencephalograph electrode/lead tester is a device used for testing the impedance (resistance to alternating current) of the electrode and lead system of an electroencephalograph to assure that an adequate contact is made between the electrode and the skin.
Electroencephalograph test signal generator
Neurological
Class BAn electroencephalograph test signal generator is a device used to test or calibrate an electroencephalograph.
Electroencephalograph tester
Neurological
Class AIntended to perform quality control procedures on an electroencephalograph (EEG) machine and/or a sleep recording machine.
Electroencephalographic electrode cap
Neurological
Class BAnalytical scalp electrodes preconfigured within a head- worn device to use with electroencephalography (EEG).
Electroencephalographic long-term ambulatory recorder
Neurological
Class BIntended to continuously record electroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders.
Electroencephalographic monitoring system
Neurological
Class CIntended to continuously measure the electrical signals produced by a patients brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. Alongwith which measuring of other physiological parameters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG.
Electromyograph
Neurological
Class BIntended in clinical diagnosis of muscular disorders to evaluate muscle weakness and to determine if the weakness is related to the muscles themselves or a problem with the nerves that supply the muscles.
Electronic Valve Setting Reader and Adjuster
Neurological
Class ANon-sterile, non-measuringAn electronic device intended to noninvasively modify the operating pressure of a programmable, non-active, implanted cerebrospinal fluid (CSF) shunt valve that is part of a CSF shunt (e.g., ventriculoperitoneal shunt, lumboperitoneal shunt). When externally placed on the location of the implanted valve, it is actuated to supply coded magnetic signals to affect mechanical changes to the pressure characteristics of the proprietary implanted valve.
Electronystagmograph
Neurological
Class BIntended for detecting the electrical potential caused by eye movements.
Epicranial brain electrical stimulation system
Neurological
Class CIntended to apply weak, pulsed (not continuous) electrical stimuli from beneath the scalp to specific areas of the brain for the treatment of focal epilepsy.
Epidural Catheter
Neurological
Class BEpidural catheter is a very thin, flexible tube that is implanted into spine
Esthesiometer
Neurological
Class AAn esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity
Extramuscular diaphragm/phrenic nerve electrical stimulation system
Neurological
Class DIntended to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve, to contract the diaphragm rhythmically (using extramuscular electrodes) and cause the patient to draw breath in a manner similar to natural breathing.
Facial nerve locating system
Neurological
Class BIntended to locate a facial nerve by applying an electrical stimulus.
Gait- enhancement electrical stimulation system, external
Neurological
Class BIntended to improve the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders by applying external electrical simulation.
Gait-enhancement electrical stimulation system, implantable
Neurological
Class DIntended to improve the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders by applying internal electrical simulation.
Gel base for metallic neuro head frame
Neurological
Class ANon-sterile, non-measuringIt is used for providing support patients head in a suitable and stable position (e.g., supine, lateral, or prone) during intracranial and spinal surgeries.
Head marking cap
Neurological
Class ANon-sterile, non-measuringA non-sterile head covering intended to be worn on the head of a patient to allow a healthcare professional to mark specific reference points on the head during a procedure [e.g., transcranial magnetic stimulation (TMS)] as an alternative to marking the scalp directly or to avoid cutting the patient’s hair.
Home seizure monitoring system
Neurological
Class CIntended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home some types may also be used in clinical settings.
Human dura mater
Neurological
Class DHuman dura mater is human pachymeninx tissue intended to repair defects in human dura mater.
Implantable pulse generator mesh bag, bioabsorbable
Neurological
Class DIntended to envelop an implantable pulse generator (IPG) (e.g., cardiac pacemaker/defibrillator, neurostimulator) to stabilize the implant in the subcutaneous pocket in which it is implanted.
Implantable spinal cord electrical stimulation system programmer
Neurological
Class CDevice designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG).
Implanted cerebellar stimulator
Neurological
Class DAn implanted cerebellar stimulator is a device used to stimulate electrically a patients cerebellar cortex for the treatment of intractable epilepsy, spasticity, and some movement disorders. The stimulator consists of an implanted receiver with electrodes that are placed on the patients cerebellum and an external transmitter for transmitting the stimulating pulses across the patients skin to the implanted receiver.
Implanted diaphragmatic/phrenic nerve stimulator
Neurological
Class DAn implanted diaphragmatic/phrenic nerve stimulator is a device that provides electrical stimulation of a patients phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical spinal cord injury, or chronic lung disease. The stimulator consists of an implanted receiver with electrodes that are placed around the patients phrenic nerve and an external transmitter for transmitting the stimulating pulses across the patients skin to the implanted receiver
Implanted intracerebral/sub cortical stimulator for pain relief
Neurological
Class DAn implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to subsurface areas of a patients brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patients brain and an external transmitter for transmitting the stimulating pulses across the patients skin to the implanted receiver.
Implanted neuromuscular stimulator
Neurological
Class DAn implanted neuromuscular stimulator is a device that provides electrical stimulation to a patients peroneal or femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of an implanted receiver with electrodes that are placed around a patients nerve and an external transmitter for transmitting the stimulating pulses across the patients skin to the implanted receiver. The external transmitter is activated by a switch in the heel in the patients shoe
Implanted spinal cord stimulator for bladder evacuation
Neurological
Class DAn implanted spinal cord stimulator for bladder evacuation is an electrical stimulator used to empty the bladder of a paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or her bladder by reflex means or by the intermittent use of catheters. The stimulator consists of an implanted receiver with electrodes that are placed on the conus medullaris portion of the patients spinal cord and an external transmitter for transmitting the stimulating pulses across the patients skin to the implanted receiver.
Intracranial pressure monitor device
Neurological
Class DIntended for intermittent or continuous measurement and display of intracranial pressure (ICP). It is used in conjunction with an invasive intracranial device.
Intramuscular diaphragm/phrenic nerve electrical stimulation system
Neurological
Class DIntended to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve to contract the diaphragm rhythmically (using intramuscular electrodes) and cause the patient to draw breath in a manner similar to natural breathing.
Intramuscular diaphragm/phrenic nerve electrical stimulation system programmer
Neurological
Class CIntended to change, telemetrically, one or more of the operating parameters (the programs) of an intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator (EPG).
Intranasal cooling system
Neurological
Class CIntended for rapid cooling induction in patients where temperature reduction is clinically indicated (e.g., following a cerebral ischemic event, during cardiac arrest) to help mimimize damage to the brain and heart.
Invasive- detection physiological monitor
Neurological
Class CIntended for continuous or intermittent measurement, display and/or recording of several invasively-detected physiological parameters [e.g., intracranial pressure (ICP), compartmental pressure].
Leukotome
Neurological
Class BIntended to cut brain tissue (i.e., cutting white matter, leukotomy).
Magnetoencephalography system
Neurological
Class BIntended to non-invasively detect, measure, and display bio- magnetic signals produced by electrically-active cortical brain tissue, and that provide diagnostic information about the location of the active tissue responsible for cognitive brain functions relative to the surrounding brain anatomy.
Manual dexterity assessment software
Neurological
Class ANon-sterile, non-measuringThe software is intended to detect micrographia (smallness of writing), bradykinesia (slowness of movement) and tremor with the help of an off-the-shelf tablet and a digital pen. This is not intended for self-assessment. This does not have a measuring function or AI- integrated features.
Manual surgical saw, flexible
Neurological
Class BIntended for cutting bone through a sawing action during neurological or orthopaedic surgery.
Meningeal prosthesis
Neurological
Class DIntended to repair the meningeal membrane (meninges).
Nasopharyngeal electrode
Neurological
Class CA nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity.
Needle electrode
Neurological
Class CA needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.
Nerve conduction velocity measurement device
Neurological
Class CA nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patients peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.
Nerve guide, bioabsorbable, animal-derived
Neurological
Class DCollagen matrix material intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps.
Nerve guide, bioabsorbable, synthetic
Neurological
Class DSynthetic material intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps.
Nerve guide, non-bioabsorbable
Neurological
Class DNon-bioabsorbable material intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps.
Neuro Pinwheel
Neurological
Class ANon-sterile, non-measuringA non-invasive, non-powered device intended for testing pain sensation.
Neurological endoscope
Neurological
Class CA neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.
Neurological stereotactic surgery system
Neurological
Class CIntended to store diagnostic images used for image-guided neurosurgery.
Neuromuscular transmission electrical skin sensor
Neurological
Class CIntended to detect electrical neuromuscular transmission (NMT) signals, for assessing the degree of neuromuscular block in a patient.
Neuromuscular transmission motion sensor
Neurological
Class BIntended to be placed on the thumb and index finger of a patient to detect movements and convert them into electrical neuromuscular transmission (NMT) signals during nerve stimulation.
Neuropsychiatric interpretive electroencephalograph assessment aid
Neurological
Class CThe neuropsychiatric interpretive electroencephalograph assessment aid is a prescription device that uses a patients electroencephalograph (EEG) to provide an interpretation of the patients neuropsychiatric condition. The neuropsychiatric interpretive EEG assessment aid is used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.
Neurosurgical chair
Neurological
Class ANon-sterile, non-measuringIntended to support and position a patient in a sitting or reclined position during neurosurgery.
Neurosurgical head holder (skull clamp)
Neurological
Class BA neurosurgical head holder (skull clamp) is a device used to clamp the patients skull to hold head and neck in a particular position during surgical procedures.
Neurosurgical headrests
Neurological
Class ANon-sterile, non-measuringA neurosurgical headrest is a device used to support the patients head during a surgical procedure.
Neurosurgical microscope
Neurological
Class BDesigned to magnify minute structures within the neurological fields for surgery, typically the brain or spine or surroundings in the performance of neurological surgical procedures which require high magnification by transmitted light.
Neurosurgical Sponge/strip
Neurological
Class DA sterile, absorbent pad intended to absorb fluids and blood from the brain during neurological procedures. This is not a dressing or an implant. This may contain X-ray detectable markers. This is a single-use device.
Non-electroencephalogram (EEG) physiological signal based seizure monitoring system
Neurological
Class CA non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure
Nonpowered neurosurgical instrument
Neurological
Class AA nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc
Olfactometry system
Neurological
Class CIntended to determine the response of humans to odours delivered through the nose, including irritants.
Percussion hammer, manual
Neurological
Class AIntended to be used by an examining physician to gently tap near a patients joints to test reflexes.
Percussion hammer, manual/ Manual percussor
Neurological
Class ANon-sterile, non-measuringIntended to be used by an examining physician to gently tap near a patients joints to test reflexes.
Percussor
Neurological
Class AA percussor is a small hammerlike device used by a physician to provide light blows to a body part. A percussor is used as a diagnostic aid during physical examinations
Percutaneous Long Term Intraspinal Catheter
Neurological
Class CTo conduct a preimplantintra spinal infusion screening trial procedure prior to implanting a pump.
Photodiode subretinal prosthesis system
Neurological
Class CDesigned to provide visual function to a patient with vision loss due to retinal degeneration by detecting light, converting it into electrical signals, and relaying them to the retina for neural stimulation.
Physical therapy ultrasound/neuromuscular stimulation system
Neurological
Class BDesigned to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by- products while applying ultrasound treatments.
Pinwheel
Neurological
Class AA pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.
Rheoencephalograph
Neurological
Class DA rheoencephalograph is a device used to estimate a patients cerebral circulation (blood flow in the brain) by electrical impedance methods with direct electrical connections to the scalp or neck area.
Rigid Optical Spinoscope
Neurological
Class BA rigid endoscope intended for the visual examination and access of the spine (cervical, thoracic, or lumbar spine) for various interventional and surgical procedures. It is not intended for visualization and treatment of brain (ventricles, hydrocephalus). This may be a reusable or single-use device.
Scalp clip
Neurological
Class CA scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.
Scoliosis- treatment electrical stimulation system
Neurological
Class DIntended to apply electrical stimuli to the spinal musculature to produce a force that stabilizes or limits the progression of the spinal lateral curvature (i.e., scoliosis).
Skull plate anvil
Neurological
Class AA skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patients skull.
Skull punch
Neurological
Class AA skull punch is a device used to punch holes through a patients skull to allow fixation of cranioplasty plates or bone flaps by wire or other means.
Skullplate screwdriver
Neurological
Class AA skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patients skull by screws.
Spinal Needles
Neurological
Class BUsed for diagnostic sampling of cerebrospinal fluid, delivering anesthetics and for the introduction of contrast medium.
Stereotactic radiosurgical system
Neurological
Class DIntended to deliver a therapeutic radiation dose to an anatomical region from external beams produced from multiple radionuclide sources arranged in a fixed focal point collimated array typically used to treat brain, neck, breast and spinal tumours.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Subcutaneous Intraspinal Port and Catheter
Neurological
Class CCatheters used for both epidural Intrathecal infusion include short-term externalized catheters and long-term catheters that are tunnelled in the subcutaneous tissue.
Tibial nerve percutaneous incontinence- control electrical stimulation system
Neurological
Class DIntended to treat urinary and/or faecal incontinence with electrical stimuli applied to the sacral nerve via percutaneous tibial nerve stimulation (PTNS).
Transcranial electrical stimulation system, continuous- current and pulsed-current
Neurological
Class BIntended for one or more psychiatricneurological therapy types [e.g., transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS)]. And to induce a state resembling that of chemically-induced anaesthesia for treating one or more psychiatric disorders which may include anxiety, depression, insomnia, and/or addiction.
Transvenous phrenic nerve electrical stimulation control unit
Neurological
Class DIntended to configure/deliver stimulation of the phrenic nerve, via a transvenous electrode, to cause contraction of the diaphragm in conjunction with mechanical ventilation to assist earlier ventilation weaning.
Tuning fork
Neurological
Class AIntended to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense.
Ultrasonic scanner calibration test block
Neurological
Class AAn ultrasonic scanner calibration test block is a block of material with known properties used to calibrate ultrasonic scanning devices (e.g., the echoencephalograph).
Vagus nerve electrical stimulation system programmer
Neurological
Class CThe strength and duration of the electrical impulses are programmed.
Ventricular Cannula
Neurological
Class BFor use in neurosurgical procedures. It is specially designed to penetrate delicate brain tissue and give continued access to brain’s ventricular system.
Ventricular Catheter
Neurological
Class CIt is used to monitor pressure in patients with brain injuries, intracranial bleeds or other brain abnormalities that lead to increased fluid build-up.
Wearable electroencephalograph (EEG) headset
Neurological
Class BA powered device intended to monitor, interpret, and provide feedback on brain activity as therapeutic support for neurological or psychological conditions such as ADHD, anxiety, or PTSD. It may also aid in improving mental states such as focus, stress management, and cognitive performance. This is a reusable device.
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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