AI DWI Mismatch V1.0
by Olea Medical S.A.S. EUDAMED
Active
Ref AP-NV-AIDM-MR
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++EOLEAIDM72 | Date29 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- AP-NV-AIDM-MR
- Primary DI / UDI-DI
- +EOLEAIDMV1P00
- Basic UDI-DI
- ++EOLEAIDM72
- EMDN Code
- Z11050182 Magnetic resonance (mr) systems - software accessories
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000002403
Other devices from Olea Medical S.A.S.
Properties
Show properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No