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acetate optical frames
EUDAMEDClass I (EU MDR)
Ref ID Tokyo GLF5910Model GLF5907/GLF5908/GLF5909/GLF5910Ref ID Tokyo GLF5908Ref ID Tokyo GLF5907Ref ENVY HS1117Ref ENVY 9643Ref ENVY ES6141
Identity
- Trade Name
- acetate optical frames EUDAMED
- Model / Reference
- GLF5907/GLF5908/GLF5909/GLF5910 EUDAMEDID Tokyo GLF5910 EUDAMEDID Tokyo GLF5908 EUDAMEDID Tokyo GLF5907 EUDAMEDENVY HS1117 EUDAMEDENVY 9643 EUDAMEDENVY ES6141 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977730470165 EUDAMED06977730470141 EUDAMED06977730470134 EUDAMED06977730470318 EUDAMED06977730470332 EUDAMED06977730470301 EUDAMED
- Basic UDI-DI
- 697773047AGK EUDAMED
- Direct Marketing DI
- 06977730470318 EUDAMED06977730470332 EUDAMED06977730470301 EUDAMED
- EMDN Code
- K01010103 OPTICAL TROCAR, SINGLE-USE EUDAMEDQ02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDRomania 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 (6)
- EUDAMED a1916732-bea9-4ac0-a917-f1aa0ca5dba6 61 fields · synced Sep 18, 2026
- EUDAMED eab9af33-2901-481c-a9e4-b095e5b0a754 61 fields · synced May 18, 2026
- EUDAMED bde6f0e1-342c-4fe1-930c-bdf67d9faec0 61 fields · synced May 19, 2026
- EUDAMED d4a4e96e-1238-41ed-9a57-dce4634f4d5f 61 fields · synced Jul 22, 2026
- EUDAMED 28c709e5-bbc6-4fbc-88ca-712a81587a93 61 fields · synced Jul 22, 2026
- EUDAMED 69c81941-a3ca-46ed-9fda-6a1dc92253ac 61 fields · synced Sep 18, 2026