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Creatine Kinase MB (Electrochemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref 691017Model 50T, 2×50T, 100T, 2×100TModel 100T
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 EUDAMED691017 EUDAMED100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341680534 EUDAMED
- Basic UDI-DI
- 69703416803205033JA EUDAMEDB-06970341680534 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 8ae89c5a-8a5f-4bbb-b11d-2cfa697a6b39 61 fields · synced Jul 8, 2026
- EUDAMED 334df36c-e0c8-4e61-b7f9-dcc4e7353076 61 fields · synced May 19, 2026