← Back to catalogue
Eyevan
EUDAMEDFDA UDIClass I (EU MDR)
Ref DD-14T 49 ECRModel Plastic/Combination
by EYEVAN Inc.
Identity
- Trade Name
- EYEVAN EUDAMEDFDA UDI
- Generic Name
- Spectacle frame FDA UDI
- Device Name
- C1 45 BKWG EUDAMED
- Model / Reference
- Plastic/Combination EUDAMEDDD-14T 49 ECR EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04582669000868 EUDAMEDFDA UDI
- Basic UDI-DI
- 458266900RXCMBM4 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
Eyevan 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 | 458266900RXCMBM4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EYEVAN Inc.
- EUDAMED SRN
- JP-MF-000028437
- Authorised Representative
- EYEVAN Europe FR-AR-000025678
Sources (2)
- EUDAMED 99d2bd24-8e15-4a31-b695-ec25e7374a24 61 fields · synced May 30, 2026
- FDA UDI 28dd4e6f-a0bf-4e9d-a5d1-ead66569d834 32 fields · synced May 30, 2026