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Creatine Kinase MB (Electrochemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 691039Model 50TModel 50T, 2×50T, 100T, 2×100T
Identity
- Trade Name
- Creatine Kinase MB (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Creatine Kinase MB (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 50T EUDAMED691039 EUDAMED50T, 2×50T, 100T, 2×100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341689339 EUDAMED
- Basic UDI-DI
- B-06970341689339 EUDAMED69703416803205033JA EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C 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
New Device
No
EUDAMED
Creatine Kinase MB (Electrochemiluminescence Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06970341689339 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970341689339 | 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 (2)
- EUDAMED 2dc5cd5a-faf5-4775-80b3-8bfe2ccda36d 61 fields · synced Jul 9, 2026
- EUDAMED b08c74ec-9ffd-49c5-a94a-929a3e909f8d 61 fields · synced May 19, 2026