Identity
- Trade Name
- BE WHITE EUDAMED
- Device Name
- Optical frame and sunglasses EUDAMED
- Model / Reference
- Otis C3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975457076516 EUDAMED
- Basic UDI-DI
- 69754570SICILOPTICVU EUDAMED
- EMDN Code
- Q02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Be White by Wenzhou Wanray Glasses 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 | 69754570SICILOPTICVU | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Wanray Glasses Co., Ltd
- EUDAMED SRN
- CN-MF-000025847
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED ef7110ed-8cc1-48c9-ba85-d7d2217150d4 61 fields · synced Jun 19, 2026