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High Sensitive Cardiac Troponin I (hs-cTnI) Assay Kit(Chemiluminescent Immunoas…
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/Kit
Identity
- Trade Name
- High Sensitive Cardiac Troponin I (hs-cTnI) Assay Kit(Chemiluminescent Immunoassay) EUDAMED
- Device Name
- High Sensitive Cardiac Troponin I (hs-cTnI) Assay Kit(Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 100 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986812800 EUDAMED
- Basic UDI-DI
- B-06974986812800 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
High Sensitive Cardiac Troponin I (hs-cTnI) Assay Kit(Chemiluminescent Immunoas… by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06974986812800 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b84ae340-00ac-4c16-93b5-83b72b6eabbd 61 fields · synced Oct 7, 2026