Identity
- Trade Name
- AudioStream Adapter & Case FDA UDI
- Generic Name
- Hearing aid/implant system functionality-enhancing device FDA UDI
- Device Name
- Audio Processor AudioStream Adapter FDA UDI
- Model / Reference
- 44786 FDA UDI
- Description
- Audio Processor AudioStream Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09008737447861 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Hearing aid/implant system functionality-enhancing device 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Hearing aid/implant system functionality-enhancing device
AudioStream Adapter & Case by Med-El Elektromedizinische Geräte Gesellschaft m.b.H. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hearing aid/implant system functionality-enhancing device.
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- GN ReSound — Gn Hearing A/S · Class II
- GN Hearing — Gn Hearing A/S · Class II
- GN Hearing — Gn Hearing A/S · Class II
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 |
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Manufacturer
Sources (1)
- FDA UDI 23eb2cdc-a8da-4410-9297-a51447610e95 35 fields · synced Jun 6, 2026