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metal optical frames
EUDAMEDClass I (EU MDR)
Ref 8641Model 8641/8655/8654/8215/8672/8663/E00003/E00008/MH00005J/MH00049J/BF4036/GLF5074/GLF5069Ref GLF5069Ref 8672Ref MH00005JRef BF4036Ref 8655Ref GLF5074Ref MH00049JRef 8654Ref 06977730470363Ref HOFFMAN 8963Ref 06977730470349
Identity
- Trade Name
- metal optical frames EUDAMEDOPTICAL FRAMES EUDAMED
- Device Name
- METAL OPTICAL FRAMES EUDAMED
- Model / Reference
- 8641/8655/8654/8215/8672/8663/E00003/E00008/MH00005J/MH00049J/BF4036/GLF5074/GLF5069 EUDAMED8641 EUDAMEDGLF5069 EUDAMED8672 EUDAMEDMH00005J EUDAMEDBF4036 EUDAMED8655 EUDAMEDGLF5074 EUDAMEDMH00049J EUDAMED8654 EUDAMED06977730470363 EUDAMEDHOFFMAN 8963 EUDAMED06977730470349 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977730470004 EUDAMED06977730470127 EUDAMED06977730470042 EUDAMED06977730470080 EUDAMED06977730470103 EUDAMED06977730470011 EUDAMED06977730470110 EUDAMED06977730470097 EUDAMED06977730470028 EUDAMED06977730470363 EUDAMED06977730470394 EUDAMED06977730470349 EUDAMED
- Basic UDI-DI
- 697773047MHB EUDAMED
- Direct Marketing DI
- 06977730470363 EUDAMED06977730470394 EUDAMED06977730470349 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
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 (12)
- EUDAMED 03f3b413-b415-417f-aa8f-93a086228f59 61 fields · synced Aug 1, 2026
- EUDAMED a668fccb-29ba-4fa2-9a11-5b3784cd5dc8 61 fields · synced May 17, 2026
- EUDAMED fcc72015-5c62-45dd-b02d-de33f1c5ef42 61 fields · synced May 17, 2026
- EUDAMED af5ab83c-8f22-4e58-be23-602955ba1ff3 61 fields · synced May 17, 2026
- EUDAMED 836298c2-a1b6-46d1-90a5-968b721c7353 61 fields · synced May 17, 2026
- EUDAMED 059965e7-4b27-4312-a1a4-7828e591f2df 61 fields · synced May 18, 2026
- EUDAMED 251aeb31-b744-4668-840e-638b6fcb7efc 61 fields · synced May 18, 2026
- EUDAMED af3dc3fa-bb28-48d2-92b6-c4708067e240 61 fields · synced May 18, 2026
- EUDAMED 04c285fc-8f43-4cdc-a1c9-7626f0c67285 61 fields · synced May 18, 2026
- EUDAMED 2717ad07-de9a-4302-851e-28cde83343e6 61 fields · synced Jul 9, 2026
- EUDAMED f25b23b4-b00c-4604-b657-fcaa464f58d8 61 fields · synced Jul 9, 2026
- EUDAMED 9b9bc8e0-0ee5-4d34-aebf-473c5282a934 61 fields · synced Aug 1, 2026