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Creatine Kinase MB STAT (CK-MB STAT) eCLIA
EUDAMEDClass C (EU MDR)
Ref 691043Model 50T, 2×50T, 100T, 2×100TModel 100T
Identity
- Trade Name
- Creatine Kinase MB STAT (CK-MB STAT) eCLIA EUDAMED
- Device Name
- Creatine Kinase MB STAT (CK-MB STAT) eCLIA EUDAMED
- Model / Reference
- 50T, 2×50T, 100T, 2×100T EUDAMED691043 EUDAMED100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341689353 EUDAMED
- Basic UDI-DI
- 69703416803205034JC EUDAMEDB-06970341689353 EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Denmark EUDAMEDGermany 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 STAT (CK-MB STAT) eCLIA by Shenzhen Lifotronic Technology Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69703416803205034JC | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 69703416803205034JC | 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 b48ac38c-dc70-4d36-9b07-57dae9336b72 61 fields · synced Jul 26, 2026
- EUDAMED b6eb4375-e89a-4da8-81aa-d8093bceb209 61 fields · synced May 17, 2026