Phonak Audeo I-R Trial
EUDAMEDFDA UDIClass IIa (EU MDR)
by Sonova AG
Identity
- Trade Name
- Phonak Audeo I-R Trial EUDAMEDPhonak Audéo I-R Trial 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 EUDAMED050-1044-P6BB EUDAMED(silver gray) FDA UDI
Identifiers
- Catalog Number
- 050-1044-P6BB FDA UDI
- Primary DI / UDI-DI
- 07613389808100 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 I-R Trial 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 2a2b1f5c-8d66-4fcd-93dc-cf940c15321a 61 fields · synced Jun 6, 2026
- FDA UDI e64bddd4-35cc-4b0e-b988-ca92281e7d19 33 fields · synced May 30, 2026