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Creatine Kinase MB (Electrochemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref 691040Model 50T, 2×50T, 100T, 2×100TModel 2×50T
Identity
- Trade Name
- Creatine Kinase MB (Electrochemiluminescence Immunoassay) EUDAMED
- Device Name
- Creatine Kinase MB (Electrochemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 50T, 2×50T, 100T, 2×100T EUDAMED691040 EUDAMED2×50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063096 EUDAMED
- Basic UDI-DI
- 69703416803205033JA EUDAMEDB-06975984063096 EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass 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
New Device
No
EUDAMED
Creatine Kinase MB (Electrochemiluminescence Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69703416803205033JA | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 69703416803205033JA | Class C | 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 6053280c-6305-4bca-89bf-d56fae624664 61 fields · synced Aug 2, 2026
- EUDAMED cf23e46e-5aca-4dfc-85bb-c2d2b10355c4 61 fields · synced May 19, 2026