← Back to catalogue
cTn-T Cardiac Troponin T (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref hs-cTnT706-AE10Y, hs-cTnT706-AE10N, hs-cTnT706-AE20Y, hs-cTnT706-AE20N
Identity
- Trade Name
- cTn-T Cardiac Troponin T (CLIA) EUDAMED
- Device Name
- cTn-T Cardiac Troponin T (CLIA) EUDAMED
- Model / Reference
- hs-cTnT706-AE10Y, hs-cTnT706-AE10N, hs-cTnT706-AE20Y, hs-cTnT706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-hs-cTnT706-AE3N EUDAMED
- Basic UDI-DI
- B-hs-cTnT706-AE3N EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
cTn-T Cardiac Troponin T (CLIA) 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-hs-cTnT706-AE3N | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 3e77500c-1f68-460c-bbc3-25253d88108e 61 fields · synced Jul 21, 2026
- EUDAMED 3e77500c-1f68-460c-bbc3-25253d88108e-1 61 fields · synced Jun 9, 2026