Identity
- Device Name
- Full rim metal optical frames EUDAMED
- Model / Reference
- 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974524210020 EUDAMED
- Basic UDI-DI
- 6974524212CX EUDAMED
- Direct Marketing DI
- 06974524210020 EUDAMED
- EMDN Code
- Q02100201 METAL SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I 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
Full rim metal optical frames by Wenzhou Deco International 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 | 6974524212CX | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Deco International Co., Ltd
- EUDAMED SRN
- CN-MF-000005869
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 5308cf05-7a0f-4a55-a6d7-64775f4f8e56 61 fields · synced Jun 19, 2026