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Cardiac Troponin I (cTnI) Test Kit (Immunofluorescence)
EUDAMEDClass IVD General (EU MDR)
Ref 52027004Model 50T/KitRef 52026004Model 25T/kit
Identity
- Trade Name
- Cardiac Troponin I (cTnI) Test Kit (Immunofluorescence) EUDAMED
- Device Name
- Cardiac Troponin I (cTnI) Test Kit (Immunofluorescence) EUDAMED
- Model / Reference
- 50T/Kit EUDAMED52027004 EUDAMED25T/kit EUDAMED52026004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FA0009ZA EUDAMED06950334804482 EUDAMED
- Basic UDI-DI
- B-FA0009ZA EUDAMEDB-06950334804482 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Bulgaria 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
Cardiac Troponin I (cTnI) Test Kit (Immunofluorescence) by Genrui Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-FA0009ZA | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED eeada0b5-a49f-4169-9e09-3db586e37cb4 61 fields · synced Jul 14, 2026
- EUDAMED 5fbb09a3-48cd-469c-863c-48466588c7ac 61 fields · synced May 19, 2026