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Eyevan7285
EUDAMEDFDA UDIClass I (EU MDR)
Ref 647 47 348901Model Plastic/Combination
by EYEVAN Inc.
Identity
- Trade Name
- EYEVAN7285 EUDAMEDFDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Device Name
- E-0513 45 BSTG EUDAMED
- Model / Reference
- Plastic/Combination EUDAMED647 47 348901 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04582669011017 EUDAMEDFDA UDI
- Basic UDI-DI
- 458266901RXCMBMH EUDAMED
- FDA Product Code
- HQZ FDA UDI
- EMDN Code
- Q02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
- GMDN Term
- Spectacle frame FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.5842 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Eyevan7285 by Eyevan Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 458266901RXCMBMH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- EYEVAN Inc.
- EUDAMED SRN
- JP-MF-000028437
- Authorised Representative
- EYEVAN Europe FR-AR-000025678
Sources (2)
- EUDAMED bd8f3b0b-4046-40ff-a4ab-46470fb9a774 61 fields · synced Jul 29, 2026
- FDA UDI 46f09a6f-a18f-4888-a628-06893e8504f1 32 fields · synced May 30, 2026