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OuïeZen 12 GS RIC R
EUDAMEDClass IIa (EU MDR)
Ref 63401-KModel Receiver-In-Canal (RIC)
Identity
- Trade Name
- OuïeZen 12 GS RIC R EUDAMED
- Device Name
- G Series AI EUDAMED
- Model / Reference
- Receiver-In-Canal (RIC) EUDAMED63401-K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840388209806 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
Category: Air-conduction hearing aid, receiver-in-canal
OuïeZen 12 GS RIC R by Starkey Laboratories Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 b319b54a-326c-4351-a884-571549fead8c 61 fields · synced Jul 17, 2026