Identity
- Trade Name
- CLIA hs-cTnI Calibrator EUDAMED
- Device Name
- CLIA hs-cTnI Calibrator EUDAMED
- Model / Reference
- CAL002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521001256 EUDAMED
- Basic UDI-DI
- B-06974521001256 EUDAMED
- EMDN Code
- W0102152204 CARDIAC MARKER STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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
CLIA hs-cTnI Calibrator by Shenzhen Superbio 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-06974521001256 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024149
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED e7ec629a-9f64-486b-a4c3-0cc60e3258ee 61 fields · synced Jul 13, 2026