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High Sensitivity Cardiac Troponin T (hs-cTnT) Test Kit (Quantum Dots Fluorescen…
EUDAMEDClass IVD General (EU MDR)
Ref A8402CC
Identity
- Trade Name
- High Sensitivity Cardiac Troponin T (hs-cTnT) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMED
- Device Name
- High Sensitivity Cardiac Troponin T (hs-cTnT) Test Kit (Quantum Dots Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- A8402CC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979469760821 EUDAMED
- Basic UDI-DI
- B-06979469760821 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
High Sensitivity Cardiac Troponin T (hs-cTnT) Test Kit (Quantum Dots Fluorescen… by Nanjing Vazyme Medical Technology Co., Ltd. — Class IVD General — IVDD…
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-06979469760821 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED d1d7ec76-5d8b-43f3-9ddd-2a08ab28c523 61 fields · synced Oct 6, 2026