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Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 0320300903Model 100 Tests/KitRef 745009Model 25 Tests/KitRef 0320300901Model 10 Tests/Kit
Identity
- Trade Name
- Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Device Name
- Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 100 Tests/Kit EUDAMED0320300903 EUDAMED25 Tests/Kit EUDAMED745009 EUDAMED10 Tests/Kit EUDAMED0320300901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984067827 EUDAMED06978139075807 EUDAMED06975984067803 EUDAMED
- Basic UDI-DI
- B-06975984067827 EUDAMEDB-06978139075807 EUDAMEDB-06975984067803 EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975984067827 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 2885212f-a84b-4a99-bccf-6469ffd1b0d6 61 fields · synced Oct 6, 2026
- EUDAMED bd563f19-ea5b-421a-8038-94a580412a0c 61 fields · synced May 18, 2026
- EUDAMED aa556d84-16d4-4ea8-8a34-62f012e52cf5 61 fields · synced May 18, 2026