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Roger 17 (02), (Velvet Black)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 052-3235-D02P8
by Phonak AG
Identity
- Trade Name
- Roger 17 (02), (Velvet Black) EUDAMEDPhonak FDA UDI
- Generic Name
- Hearing aid enhanced audio device, teaching-environment FDA UDI
- Device Name
- Wireless HA receivers EUDAMEDRoger 17 (02) (velvet black) FDA UDI
- Model / Reference
- 052-3235-D02P8 EUDAMEDFDA UDI
- Description
- Roger 17 (02) (velvet black) FDA UDI
Identifiers
- Catalog Number
- 052-3235-D02P8 FDA UDI
- Primary DI / UDI-DI
- 07612904280216 EUDAMEDFDA UDI
- Basic UDI-DI
- 07612904WRASPQ EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Hearing aid enhanced audio device, teaching-environment FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Roger 17 (02), (Velvet Black) by Phonak AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 07612904WRASPQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Phonak AG
- EUDAMED SRN
- CH-MF-000015960
- Authorised Representative
- Sonova Deutschland GmbH DE-AR-000006322
Sources (2)
- EUDAMED 444b805f-a602-434c-98af-4149b867a6da 61 fields · synced Jun 19, 2026
- FDA UDI 47eb4c3c-bf19-4f4a-8021-82b99302dcf6 35 fields · synced May 30, 2026