Identity
- Trade Name
- OPTICAL FRAMES EUDAMED
- Device Name
- OPTICAL FRAMES EUDAMED
- Model / Reference
- KOM-O9078 EUDAMED06978916011035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978916011035 EUDAMED
- Basic UDI-DI
- 6978916019078GX EUDAMED
- Direct Marketing DI
- 06978916011035 EUDAMED
- EMDN Code
- Q02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Optical Frames by Wenzhou New Standing Eyewear Co., Ltd. — Class I — 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 | 6978916019078GX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wenzhou New Standing Eyewear Co., Ltd.
- EUDAMED SRN
- CN-MF-000030477
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 38ab79d1-9394-4e71-97d5-426709fd3626 61 fields · synced Jun 18, 2026