Identity
- Trade Name
- Auria™ Harmony™ Processor FDA UDI
- Generic Name
- Cochlear implant/auditory brainstem implant sound processor FDA UDI
- Device Name
- Beige FDA UDI
- Model / Reference
- CI-5235-300 FDA UDI
- Description
- Beige FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840094401389 FDA UDI
- PMA Number
- P960058 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
No
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
No
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
Auria™ Harmony™ Processor by Advanced Bionics — 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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- Nucleus — Cochlear · Class III
Cleared under the same submission
P960058 also covers:
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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
- Advanced Bionics
Sources (1)
- FDA UDI 56c451f1-79ee-48af-8936-d0b81f886a83 36 fields · synced Jun 8, 2026