Identity
- Trade Name
- Optical Frames EUDAMED
- Device Name
- Optical Frames EUDAMED
- Model / Reference
- PF02 EUDAMED2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976215590091 EUDAMED
- Basic UDI-DI
- 6976215590091C5 EUDAMED
- Direct Marketing DI
- 06976215590091 EUDAMED
- EMDN Code
- Q02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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 101 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 | 6976215590091C5 | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou 101 Optical Co., Ltd.
- EUDAMED SRN
- CN-MF-000034399
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 884c1afd-44fb-422a-9fff-009fe9983672 61 fields · synced Jun 19, 2026