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metal optical frames
EUDAMEDClass I (EU MDR)
Ref E00008Model 8641/8655/8654/8215/8672/8663/E00003/E00008/MH00005J/MH00049J/BF4036/GLF5074/GLF5069
Identity
- Trade Name
- metal optical frames EUDAMED
- Device Name
- METAL OPTICAL FRAMES EUDAMED
- Model / Reference
- 8641/8655/8654/8215/8672/8663/E00003/E00008/MH00005J/MH00049J/BF4036/GLF5074/GLF5069 EUDAMEDE00008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977730470073 EUDAMED
- Basic UDI-DI
- 697773047MHB EUDAMED
- EMDN Code
- K01010103 OPTICAL TROCAR, SINGLE-USE 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
metal 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 | 697773047MHB | 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 90ede273-408a-4111-a365-1f12ec437237 61 fields · synced Jun 18, 2026