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OuïeZen 12 GS RIC 312
EUDAMEDClass IIa (EU MDR)
Ref 63407-KModel Receiver-In-Canal (RIC)
Identity
- Trade Name
- OuïeZen 12 GS RIC 312 EUDAMED
- Device Name
- G Series AI EUDAMED
- Model / Reference
- Receiver-In-Canal (RIC) EUDAMED63407-K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840388209578 EUDAMED
- Basic UDI-DI
- 0842318163406V3 EUDAMED
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
OuïeZen 12 GS RIC 312 by Starkey Laboratories Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0842318163406V3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Starkey Laboratories Inc.
- EUDAMED SRN
- US-MF-000014382
- Authorised Representative
- Starkey Laboratories (Germany) GmbH DE-AR-000010831
Sources (1)
- EUDAMED 1d7cecb0-e0a0-4cd8-8ede-b2fadd5d22c8 61 fields · synced Jul 12, 2026