Identity
- Trade Name
- Optical frames EUDAMED
- Device Name
- Optical Frames EUDAMED
- Model / Reference
- FMO-255 C2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974384065822 EUDAMED
- Basic UDI-DI
- 697438406OPGLRU EUDAMED
- Direct Marketing DI
- 06974384065822 EUDAMED
- EMDN Code
- Q02100202 PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Innovision Optical 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 | 697438406OPGLRU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wenzhou Innovision Optical Co., Ltd
- EUDAMED SRN
- CN-MF-000009602
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 9dd5f519-6931-4274-ad32-2ab6a7e54780 61 fields · synced Jun 19, 2026