Cormay Ck-Mb Calibrator
Ref 5-182Model CORMAY CK-MB CALIBRATOR
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05907514651825 | Date23 Jul 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- Withdrawn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/IVDD Active
Specification
- Device Name
- Ck-Mb Calibrator
- Model / Reference
- CORMAY CK-MB CALIBRATOR, 5-182
- Primary DI / UDI-DI
- 05907514651825
- Basic UDI-DI
- B-05907514651825
- EMDN Code
- W0101050302 Calibrators single component (cc)
- Device Class
- Class IVD General
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000023053
Other devices from PZ CORMAY Spółka Akcyjna
Properties
Other properties (7)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No