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Eyevan
EUDAMEDClass I (EU MDR)
Ref E-0505(47) 47 SMKGModel Q02100203
by EYEVAN Inc.
Identity
- Trade Name
- EYEVAN EUDAMED
- Device Name
- Metal and plastic spectacle frames without lenses EUDAMED
- Model / Reference
- Q02100203 EUDAMEDE-0505(47) 47 SMKG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582667973119 EUDAMED
- Basic UDI-DI
- 458266797RXCMBTJ EUDAMED
- EMDN Code
- Q02100203 METAL AND 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
Eyevan by Eyevan Inc. — 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 | 458266797RXCMBTJ | Class I | Active |
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Manufacturer
- Manufacturer
- EYEVAN Inc.
- EUDAMED SRN
- JP-MF-000028437
- Authorised Representative
- EYEVAN Europe FR-AR-000025678
Sources (1)
- EUDAMED e33a9247-7f3c-4d55-8e69-a93c5158443e 61 fields · synced May 21, 2026