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E5 eyevan
EUDAMEDClass I (EU MDR)
Ref P13 48 BRHWGModel Plastic/Combination
by EYEVAN Inc.
Identity
- Trade Name
- E5 eyevan EUDAMED
- Device Name
- C1 45 BKWG EUDAMED
- Model / Reference
- Plastic/Combination EUDAMEDP13 48 BRHWG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582669003487 EUDAMED
- Basic UDI-DI
- 458266900RXCMBM4 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
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 | 458266900RXCMBM4 | 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 d48e4822-7cbb-4730-a9d2-4a51ba2cd57e 61 fields · synced May 22, 2026