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Creatine Kinase MB Isozyme Kit (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref FG1404YModel 100T
Identity
- Trade Name
- Creatine Kinase MB Isozyme Kit (CLIA) EUDAMED
- Device Name
- Creatine Kinase MB Isozyme Kit (CLIA) EUDAMED
- Model / Reference
- 100T EUDAMEDFG1404Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595751543 EUDAMED
- Basic UDI-DI
- B-06936595751543 EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Creatine Kinase MB Isozyme Kit (CLIA) by Medicalsystem Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06936595751543 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 38716a6c-bf2d-490d-9fac-0f3fd4050f63 61 fields · synced Jul 28, 2026