CanRisk
by The Chancellor, Masters, and Scholars of the University of Cambridge
Ref v4.0.0
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number50700038429v4.0.0NP 05070003842964 | Date31 Dec 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- v4.0.0
- Primary DI / UDI-DI
- 05070003842964
- Basic UDI-DI
- 50700038429v4.0.0NP
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class I
- Special Device Type
- Software
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- UK-MF-000051165
- Authorised representative
- Medical Device Management Ltd IE-AR-000002496
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