icobrain mr
Ref 5.15.z
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++B621ICOBRAINMREN +B621ICOBRAINMR5X15Y0 | Date27 May 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 5.15.z
- Primary DI / UDI-DI
- +B621ICOBRAINMR5X15Y0
- Basic UDI-DI
- ++B621ICOBRAINMREN
- Direct Marketing DI
- +B621ICOBRAINMR5X15Y0
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class IIa
- Special Device Type
- Software
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000006329
Other devices from icometrix NV
Properties
Other properties (12)
- 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
- Incorporates Medicinal Product: No