Identity
- Trade Name
- METAL FRAMES EUDAMED
- Device Name
- METAL FRAMES EUDAMED
- Model / Reference
- MASSIEYEWEAR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976269280016 EUDAMED
- Basic UDI-DI
- 6976269280009FB EUDAMED
- Direct Marketing DI
- 06976269280016 EUDAMED
- EMDN Code
- Q02100201 METAL SPECTACLE FRAMES WITHOUT LENSES 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 Frames by Shenzhen Borden 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 | 6976269280009FB | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Borden Optical Co., Ltd
- EUDAMED SRN
- CN-MF-000035097
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 5aacbd52-1da8-42b7-99e1-4ba5332fe10e 61 fields · synced Jul 8, 2026