Electronic Check Card
by Trukera Medical EUDAMED
Active
Ref 100004R
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number0853539002B0006HF | Date2 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- 100004R
- Primary DI / UDI-DI
- 00853539002478
- Basic UDI-DI
- 0853539002B0006HF
- EMDN Code
- W0299 IVD instruments - other
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000033261
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Companion Diagnostics: No
- New Device: No