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Cardiac Troponin I Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013909Model 2×50 tests/kitRef 3013757Model 1×50 tests/kit
Identity
- Trade Name
- Cardiac Troponin I Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Cardiac Troponin I Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50 tests/kit EUDAMED3013909 EUDAMED1×50 tests/kit EUDAMED3013757 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202224058 EUDAMED06925794520333 EUDAMED
- Basic UDI-DI
- B-06942202224058 EUDAMEDB-06925794520333 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
Yes
EUDAMED
Microbial Substances
Yes
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
Cardiac Troponin I Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial 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-06942202224058 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED fb82f6bc-8d74-4e8b-b044-0cebaac486c5 61 fields · synced Jul 30, 2026
- EUDAMED d5a98c9a-7ea0-4365-82be-dce23ec6383d 61 fields · synced May 19, 2026