Identity
- Device Name
- optical frames EUDAMEDFull rim plastic optical frames EUDAMED
- Model / Reference
- 08435171023947 EUDAMED001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435171023947 EUDAMED06974524210013 EUDAMED
- Basic UDI-DI
- 84351710228J EUDAMED6974524211CV EUDAMED
- Direct Marketing DI
- 08435171023947 EUDAMED06974524210013 EUDAMED
- EMDN Code
- Q02100202 PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDGermany 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 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 | 84351710228J | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wenzhou Deco International Co., Ltd
- EUDAMED SRN
- CN-MF-000005869
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED bfbcd2af-4dd2-4346-a308-e6d207593af7 61 fields · synced Jul 18, 2026
- EUDAMED b6549d15-cec4-464e-86ce-12e371c45b9b 61 fields · synced May 19, 2026