Creatine Kinase (CK)/Creatine Kinase Isoenzyme MB (CK-MB)/Lactate Dehydrogenase (LDH)/α-Hydroxybutyrate Dehydrogenase (HBDH) Detection Kit (Rate Method)
by Jiangsu Confidence Medical Technology Co., Ltd 6 variants
Ref 15 tests/kit
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-0697935592176643 D-0697935592176643 | Date30 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- Withdrawn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/IVDD Active
Specification
- Device Name
- Creatine Kinase (CK)/Creatine Kinase Isoenzyme MB (CK-MB)/Lactate Dehydrogenase (LDH)/α-Hydroxybutyrate Dehydrogenase (HBDH) Detection Kit (Rate Method)
- Model / Reference
- 15 tests/kit
- Primary DI / UDI-DI
- D-0697935592176643
- Basic UDI-DI
- B-0697935592176643
- EMDN Code
- W01029099 Immunochemistry reagents - other
- Device Class
- Class IVD General
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000050949
- Authorised representative
- JOYSUN GROUP S.L.U ES-AR-000043666
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No