Identity
- Trade Name
- Neuro Cochlear Implant System FDA UDI
- Generic Name
- Cochlear implant/auditory brainstem implant sound processor FDA UDI
- Device Name
- PACKING SET, NEURO2 ZTI EXCHANGE BOX C094 FDA UDI
- Model / Reference
- 181525 FDA UDI
- Description
- PACKING SET, NEURO2 ZTI EXCHANGE BOX C094 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663227001839 FDA UDI
- PMA Number
- P200021 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant/auditory brainstem implant sound processor FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cochlear implant/auditory brainstem implant sound processor
Neuro Cochlear Implant System by Neurelec — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cochlear implant/auditory brainstem implant sound processor.
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- SONNET 3 Kit (Me1712) BAT FTE White — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class III
- SONNET 3 EAS Kit (Me1720) BAT FTE Ngry — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class III
- Nucleus — Cochlear · Class III
Cleared under the same submission
P200021 also covers:
- Neuro Cochlear Implant System — NEURELEC
- Neuro Cochlear Implant System — NEURELEC
- Neuro Cochlear Implant System — NEURELEC
- Neuro Cochlear Implant System — NEURELEC
- Neuro Cochlear Implant System — NEURELEC
- Neuro Cochlear Implant System — NEURELEC
- Neuro Cochlear Implant System — NEURELEC
- Neuro Cochlear Implant System — NEURELEC
- Neuro Cochlear Implant System — NEURELEC
- Neuro Cochlear Implant System — NEURELEC
- Neuro Cochlear Implant System — NEURELEC
- Neuro Cochlear Implant System — NEURELEC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neurelec
Sources (1)
- FDA UDI d5514e02-fd5c-4d1e-98d6-0c18c632b7d8 35 fields · synced May 30, 2026