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cTnI Assay Kit CLIA
EUDAMEDClass IVD General (EU MDR)
Ref SUPM038072Ref SUPM038036
Identity
- Trade Name
- cTnI Assay Kit CLIA EUDAMED
- Device Name
- cTnI Assay Kit CLIA EUDAMED
- Model / Reference
- SUPM038072 EUDAMEDSUPM038036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974521001423 EUDAMED06974521001416 EUDAMED
- Basic UDI-DI
- B-06974521001423 EUDAMEDB-06974521001416 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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 Assay Kit CLIA 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-06974521001423 | 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 (2)
- EUDAMED c8a1637c-4289-4be9-9e0b-662eeb0ddb1a 61 fields · synced Jul 29, 2026
- EUDAMED 8edabf42-faca-40af-a5f2-a7e77fa38073 61 fields · synced May 19, 2026