Identity
- Trade Name
- OuieZen 16 SK ED CIC EUDAMED
- Device Name
- Edge AI Custom EUDAMED
- Model / Reference
- 72098-OPT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840388204733 EUDAMED
- Basic UDI-DI
- 0842318172096VE EUDAMED
- EMDN Code
- Y2145060203 HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC) 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
OuieZen 16 SK ED CIC 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 | 0842318172096VE | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Starkey Laboratories Inc.
- EUDAMED SRN
- US-MF-000014382
- Authorised Representative
- Starkey Laboratories (Germany) GmbH DE-AR-000010831
Sources (1)
- EUDAMED 95776ead-f25b-4f51-952b-6d00b062c906 61 fields · synced Jul 17, 2026