Phonak Audeo I90-Sphere (BP)
EUDAMEDFDA UDIClass IIa (EU MDR)
by Sonova AG
Identity
- Trade Name
- Phonak Audeo I90-Sphere (BP) EUDAMEDPhonak Audéo I90-Sphere FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- Sonova RIC hearing aids EUDAMED
- Model / Reference
- Sonova RIC hearing aids EUDAMED050-1029-P7B3 EUDAMED(graphite gray) FDA UDI
Identifiers
- Catalog Number
- 050-1029-P7B3 FDA UDI
- Primary DI / UDI-DI
- 07613389753219 EUDAMEDFDA UDI
- Basic UDI-DI
- 07613389RICWJ EUDAMED
- FDA Product Code
- OSM FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, receiver-in-canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI874.3400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Air-conduction hearing aid, receiver-in-canal
Phonak Audeo I90-Sphere (BP) by Sonova AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 07613389RICWJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sonova AG
- EUDAMED SRN
- CH-MF-000015958
- Authorised Representative
- Sonova Deutschland GmbH DE-AR-000006322
Sources (2)
- EUDAMED f4bfd6cb-fcdf-4604-9d7a-bcb27ff92eed 61 fields · synced Oct 6, 2026
- FDA UDI 5f6c7e49-da97-45a8-b15e-22db3acd5094 33 fields · synced May 29, 2026