Identity
- Trade Name
- Optical frame EUDAMED
- Device Name
- optical frame EUDAMED
- Model / Reference
- Free Style F42552 C1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976752175072 EUDAMED
- Basic UDI-DI
- 6976752170015DP EUDAMED
- EMDN Code
- Q02100203 METAL AND PLASTIC 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
Optical frame by Danyang Suntex Imp. & Exp. 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 | 6976752170015DP | Class I | Active |
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Manufacturer
- Manufacturer
- Danyang Suntex Imp. & Exp. Co., Ltd.
- EUDAMED SRN
- CN-MF-000037222
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED e583e7fc-929e-4966-98f8-43dbd1bc865c 61 fields · synced Jun 18, 2026