Identity
- Trade Name
- METAL OPTICAL FRAME EUDAMED
- Device Name
- METAL OPTICAL FRAME EUDAMED
- Model / Reference
- KOM EUDAMED16976919110004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976919110004 EUDAMED
- Basic UDI-DI
- 697691911CY0001MFUW EUDAMED
- Direct Marketing DI
- 16976919110004 EUDAMED
- EMDN Code
- Q02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 Frame by Wenzhou Chengye 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 | 697691911CY0001MFUW | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Chengye Optical Co., Ltd.
- EUDAMED SRN
- CN-MF-000036901
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 186d94b6-e994-4f9b-9389-d9059c857fb6 61 fields · synced Jun 19, 2026