Identity
- Trade Name
- E5 eyevan EUDAMED
- Device Name
- Plastic spectacle frames without lenses EUDAMED
- Model / Reference
- Plastic EUDAMEDP26E 47 BCST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582669060008 EUDAMED
- Basic UDI-DI
- 458266906RXPLARE 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
E5 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 | 458266906RXPLARE | 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 4593efe7-39d2-4eb1-a39b-5a0663409a62 61 fields · synced May 29, 2026