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Troponin I (TnI) Test Kit (Latex Enhanced Immunoturbidimetric)
EUDAMEDClass IVD General (EU MDR)
Ref R1:18mL×4 R2:6mL×4（709）Ref R1:60mL×2 R2:20mL×2（701）Ref R1:18mL×1 R2:6mL×1（702）Ref Calibrator：1mL×5（91034）Ref Calibrator：1mL×6（91138）
Identity
- Trade Name
- Troponin I (TnI) Test Kit (Latex Enhanced Immunoturbidimetric) EUDAMED
- Device Name
- Troponin I (TnI) Test Kit (Latex Enhanced Immunoturbidimetric) EUDAMED
- Model / Reference
- R1:18mL×4 R2:6mL×4（709） EUDAMEDR1:60mL×2 R2:20mL×2（701） EUDAMEDR1:18mL×1 R2:6mL×1（702） EUDAMEDCalibrator：1mL×5（91034） EUDAMEDCalibrator：1mL×6（91138） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674869207 EUDAMED06971674869191 EUDAMED06971674869214 EUDAMED06971674868002 EUDAMED06936895302988 EUDAMED
- Basic UDI-DI
- B-06971674869207 EUDAMEDB-06971674869191 EUDAMEDB-06971674869214 EUDAMEDB-06971674868002 EUDAMEDB-06936895302988 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
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
Troponin I (TnI) Test Kit (Latex Enhanced Immunoturbidimetric) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06971674869207 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (5)
- EUDAMED d4734bac-0780-4106-a37d-f6e7aa6733b3 61 fields · synced Oct 7, 2026
- EUDAMED fbb1eeda-06a2-4664-9975-753fe062c507 61 fields · synced May 17, 2026
- EUDAMED bba3c661-1b9d-4081-affc-aae6adf2da19 61 fields · synced May 18, 2026
- EUDAMED 9aa59da5-1980-434f-b8e9-c2a215b6b7d2 61 fields · synced May 18, 2026
- EUDAMED dfdab808-d0ed-42c0-85fd-64e081eb515a 61 fields · synced May 18, 2026