Identity
- Trade Name
- cTnI Rapid Test EUDAMED
- Device Name
- cTnI Rapid Test EUDAMED
- Model / Reference
- CTNI-D02a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CTNI-D02aBT EUDAMED
- Basic UDI-DI
- B-CTNI-D02aBT EUDAMED
- EMDN Code
- W0102160703 TROPONIN I/T - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
cTnI Rapid Test by Hangzhou Aichek Medical Technology Co., Ltd. — 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-CTNI-D02aBT | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 1798652a-b614-431f-bbbf-5f9d67fd0ccf 61 fields · synced Jun 20, 2026