Identity
- Trade Name
- OPTICAL FRAMES EUDAMED
- Device Name
- OPTICAL FRAMES EUDAMED
- Model / Reference
- 151501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251975113707 EUDAMED
- Basic UDI-DI
- 42519751VRKSTE EUDAMED
- EMDN Code
- Q02100203 METAL AND PLASTIC 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
Optical Frames by Wenzhou Yas 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 | 42519751VRKSTE | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Yas Optical Co., Ltd.
- EUDAMED SRN
- CN-MF-000047888
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED b1993fdd-99ff-43d6-9b2f-4e90622fdfe2 61 fields · synced Jun 14, 2026