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Prescription Eyeglass Frames
EUDAMEDClass I (EU MDR)
Ref 6923278627905Model Stepper Classic Series
Identity
- Device Name
- Prescription Eyeglass Frames EUDAMED
- Model / Reference
- Stepper Classic Series EUDAMED6923278627905 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923278627905 EUDAMED
- Basic UDI-DI
- 69735007935W7 EUDAMED
- EMDN Code
- Q02100202 PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Prescription Eyeglass Frames by Arts Opti Lab (Shenzhen)Company Limited — 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 | 69735007935W7 | Class I | Active |
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Manufacturer
- Manufacturer
- Arts Opti Lab (Shenzhen)Company Limited
- EUDAMED SRN
- CN-MF-000023737
- Authorised Representative
- Patient Guard Europe UG DE-AR-000007523
Sources (1)
- EUDAMED 6ca4765b-f7d5-4af5-b4f8-6ce832db0806 61 fields · synced Jun 18, 2026