Identity
- Device Name
- FULL RIM PLASTIC SUNGLASSES EUDAMED
- Model / Reference
- R21371-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974600432971 EUDAMED
- Basic UDI-DI
- 697460043SFPS2 EUDAMED
- EMDN Code
- Q0210030102 READY TO WEAR PLASTIC SPECTACLES WITH ORGANIC 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
Full Rim Plastic Sunglasses by Wenzhou Sense 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 | 697460043SFPS2 | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Sense Optical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009540
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED edb168c5-cf1d-4805-a4c0-b27140cf25d4 61 fields · synced Jul 16, 2026