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Optical Frames
EUDAMEDClass I (EU MDR)
Ref 06978985190082Model KOM-O8875 Clara White Gold
Identity
- Trade Name
- OPTICAL FRAMES EUDAMED
- Device Name
- OPTICAL FRAMES EUDAMED
- Model / Reference
- KOM-O8875 Clara White Gold EUDAMED06978985190082 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978985190082 EUDAMED
- Basic UDI-DI
- 697898519O8875TF EUDAMED
- Direct Marketing DI
- 06978985190082 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
Optical Frames by Ray Jet Optical 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 | 697898519O8875TF | Class I | Active |
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Manufacturer
- Manufacturer
- Ray Jet Optical Limited
- EUDAMED SRN
- CN-MF-000047061
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 20d36b0d-4423-4273-8a57-cef3554d3135 61 fields · synced Jun 19, 2026