Identity
- Trade Name
- EYEVAN7285 EUDAMED
- Device Name
- Metal spectacle frames without lenses EUDAMED
- Model / Reference
- Metal EUDAMED1011 47 825 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582669048600 EUDAMED
- Basic UDI-DI
- 458266904RXMTLRK EUDAMED
- EMDN Code
- Q02100201 METAL 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
Eyevan7285 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 | 458266904RXMTLRK | 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 f0c05179-b5ba-4777-a0ae-32d8b2b5f533 61 fields · synced May 22, 2026