Ck-Mb Fl Ifcc/Dgkc
by Chema Diagnostica Srl EUDAMED
Active
Ref MB 6U140
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08033650844566 | Date22 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- MB 6U140
- Primary DI / UDI-DI
- 08033650844566
- Basic UDI-DI
- B-08033650844566
- EMDN Code
- W01010114 Creatine kinase - mb activity (cc)
- Device Class
- Class IVD General
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000009128
Other devices from Chema Diagnostica Srl
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No