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AIRIS Vento
EUDAMEDClass IIa (EU MDR)
Ref Flexible Body coil(L) MR-QFC-103N for AIRIS Vento
Identity
- Trade Name
- AIRIS Vento EUDAMED
- Device Name
- AIRIS Vento EUDAMED
- Model / Reference
- Flexible Body coil(L) MR-QFC-103N for AIRIS Vento EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04573596202197 EUDAMED
- Basic UDI-DI
- 457359620103000000000032R EUDAMED
- EMDN Code
- Z11050102 OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AIRIS Vento by FUJIFILM Corporation — 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 | 457359620103000000000032R | Class IIa | Active |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
- EUDAMED SRN
- JP-MF-000010401
- Authorised Representative
- FUJIFILM Healthcare Europe GmbH DE-AR-000040920
Sources (1)
- EUDAMED bbe0d99e-e7b3-412d-b729-7b07ef621818 61 fields · synced Jun 18, 2026