Identity
- Device Name
- VUNO Med-Fundus AI EUDAMED
- Model / Reference
- VN-M-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800045800076 EUDAMED
- Basic UDI-DI
- 88000458VFSZ7 EUDAMED
- Direct Marketing DI
- 08800045800076 EUDAMED
- EMDN Code
- Z12120192 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain 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
VUNO Med-Fundus AI by VUNO Inc. — 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 | 88000458VFSZ7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- VUNO Inc.
- EUDAMED SRN
- KR-MF-000022266
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 3f981e18-c51b-41ce-97bd-c8dedf3ea51a 61 fields · synced Jul 21, 2026