← Back to catalogue
hs-cTnI STAT (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320513401Model 50TRef 0320513402Model 2×50TRef 0320513403Model 100T
Identity
- Trade Name
- hs-cTnI STAT (eCLIA) EUDAMED
- Device Name
- hs-cTnI STAT (eCLIA) EUDAMED
- Model / Reference
- 50T EUDAMED0320513401 EUDAMED2×50T EUDAMED0320513402 EUDAMED100T EUDAMED0320513403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139071724 EUDAMED06978139071731 EUDAMED06978139071748 EUDAMED
- Basic UDI-DI
- B-06978139071724 EUDAMEDB-06978139071731 EUDAMEDB-06978139071748 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
hs-cTnI STAT (eCLIA) by Shenzhen Lifotronic 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-06978139071724 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 83f728c7-f1d0-473f-a186-792ed5f06dfc 61 fields · synced Jul 25, 2026
- EUDAMED 8200767d-645c-4dcc-a2f7-75c0a2cbb3a5 61 fields · synced May 16, 2026
- EUDAMED acb16dc7-fe8e-4269-9bd9-03910db7ef5d 61 fields · synced May 19, 2026