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Cardiac Troponin I Reagent Kit (latex Enhanced Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3021609Model R1: 1x45mL, R2: 1x15mL， Calibration sample: 5x0.5mL, Control: 2x0.5mL
Identity
- Trade Name
- CARDIAC TROPONIN I REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD) EUDAMED
- Device Name
- CARDIAC TROPONIN I REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD) EUDAMED
- Model / Reference
- R1: 1x45mL, R2: 1x15mL， Calibration sample: 5x0.5mL, Control: 2x0.5mL EUDAMED3021609 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794592552 EUDAMED
- Basic UDI-DI
- B-06925794592552 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 Reagent Kit (latex Enhanced Immunoturbidimetric Method) 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-06925794592552 | 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 (1)
- EUDAMED 4523b6c3-39ff-4a97-85a3-3518cee94c9d 61 fields · synced Jul 16, 2026