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High-sensitivity Cardiac Troponin I Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kitRef 215C60001Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kitRef 150tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle ) 150tests/kit
Identity
- Device Name
- High-sensitivity Cardiac Troponin I Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EUDAMED50tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit EUDAMED215C60001 EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle ) 150tests/kit EUDAMED150tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719601929 EUDAMED06972719601912 EUDAMED06972719601240 EUDAMED06972719605293 EUDAMED06972719605927 EUDAMED
- Basic UDI-DI
- B-06972719601929 EUDAMEDB-06972719601912 EUDAMEDB-06972719601240 EUDAMEDB-06972719605293 EUDAMEDB-06972719605927 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
High-sensitivity Cardiac Troponin I Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech 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-06972719601929 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000024838
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED 12953d72-9d13-41f9-ad08-732e9aa04667 61 fields · synced Oct 6, 2026
- EUDAMED f3be49cb-abfe-4e51-9922-d6cfcb16fb5f 61 fields · synced May 11, 2026
- EUDAMED 0a3027f8-9f58-40a4-91f0-89ab1ecacf12 61 fields · synced May 19, 2026
- EUDAMED d544a079-5474-43e0-b43b-94619386b92f 61 fields · synced May 19, 2026
- EUDAMED b1694d61-1cee-4921-9593-8fc74773101f 61 fields · synced Aug 2, 2026