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acetate optical frames
EUDAMEDClass I (EU MDR)
Ref ENVY HS1112Model GLF5907/GLF5908/GLF5909/GLF5910
Identity
- Trade Name
- acetate optical frames EUDAMED
- Model / Reference
- GLF5907/GLF5908/GLF5909/GLF5910 EUDAMEDENVY HS1112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977730470295 EUDAMED
- Basic UDI-DI
- 697773047AGK EUDAMED
- Direct Marketing DI
- 06977730470295 EUDAMED
- EMDN Code
- Q02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
acetate optical frames by Wenzhou XinRui Glasses 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 | 697773047AGK | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou XinRui Glasses Co., Ltd.
- EUDAMED SRN
- CN-MF-000043362
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 5774f87a-be8c-474e-b7ab-1014d0a043d1 61 fields · synced Jun 19, 2026