Identity
- Device Name
- Metal Full Rim EUDAMED
- Model / Reference
- R26396-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974600430175 EUDAMED
- Basic UDI-DI
- 697460043FFMPT EUDAMED
- EMDN Code
- Q02100201 METAL 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
Metal Full Rim 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 | 697460043FFMPT | 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 de51b40b-301d-416b-9c92-4c4a4d6a066b 61 fields · synced Jun 19, 2026