Identity
- Trade Name
- VisionOne VFT EUDAMED
- Device Name
- VisionOne VFT EUDAMED
- Model / Reference
- VO.004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649990085098 EUDAMED
- Basic UDI-DI
- 7649990085VO.004NG EUDAMED
- EMDN Code
- Z1212012001 VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
VisionOne VFT by PeriVision SA — Class IIa — 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 | 7649990085VO.004NG | Class IIa | Active |
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Manufacturer
- Manufacturer
- PeriVision SA
- EUDAMED SRN
- CH-MF-000047664
- Authorised Representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Sources (1)
- EUDAMED 570c00b6-9c7a-4aaf-9e34-fb6b768c55fb 61 fields · synced Jun 19, 2026