Identity
- Device Name
- Optical Frame EUDAMED
- Model / Reference
- VP040C1 EUDAMEDVP042C4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976289924242 EUDAMED
- Basic UDI-DI
- 697628992000RA EUDAMED
- EMDN Code
- Q02100201,Q02100202,Q02100203,Q02100299 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 Frame by Wenzhou Newyearn Import&Export 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 | 697628992000RA | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Newyearn Import&Export Co., Ltd
- EUDAMED SRN
- CN-MF-000021354
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED b29952ed-575c-43d3-b578-1bd1e8149fd5 61 fields · synced Jun 18, 2026