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Cardiac Troponin I Kit(Latex-Enhanced Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ423YModel 50mL（R1:1×40mL+R2:1×10mL）;Calibrator:6×0.5mL;Control:2×0.5mL
Identity
- Trade Name
- Cardiac Troponin I Kit(Latex-Enhanced Immunoturbidimetric Method) EUDAMED
- Device Name
- Cardiac Troponin I Kit(Latex-Enhanced Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 50mL（R1:1×40mL+R2:1×10mL）;Calibrator:6×0.5mL;Control:2×0.5mL EUDAMEDMJ423Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595750430 EUDAMED
- Basic UDI-DI
- B-06936595750430 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T 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
Cardiac Troponin I Kit(Latex-Enhanced Immunoturbidimetric Method) by Medicalsystem Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06936595750430 | 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 d6dedd9f-5c24-4c05-8503-e7e2c8d849f0 61 fields · synced Jun 18, 2026