Identity
- Trade Name
- ACETATE OPTICAL FRAME EUDAMED
- Device Name
- ACETATE OPTICAL FRAME EUDAMED
- Model / Reference
- KOM EUDAMED16976919110011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976919110011 EUDAMED
- Basic UDI-DI
- 697691911CY0001AFTS EUDAMED
- Direct Marketing DI
- 16976919110011 EUDAMED
- EMDN Code
- Q02100202 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
Acetate 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 | 697691911CY0001AFTS | 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 5134cf90-78bf-45f5-937e-3d6a28d018fb 61 fields · synced Jul 11, 2026