Identity
- Device Name
- Optical Frames EUDAMED
- Model / Reference
- Plastic full rim EUDAMEDBORABLRD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977944420017 EUDAMED
- Basic UDI-DI
- 697794442OPFZ7 EUDAMED
- Direct Marketing DI
- 06977944420017 EUDAMED
- EMDN Code
- Q02100202 PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Frames by Wenzhou Kaibang Optical 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 | 697794442OPFZ7 | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Kaibang Optical Co., Ltd
- EUDAMED SRN
- CN-MF-000018328
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED b5246563-ab4c-40a0-be19-76bda0dc7146 61 fields · synced Jun 18, 2026