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Cardiac Troponin I（cTnI）Detection Kit（Magnetic Solid Phase Chemiluminescent Imm…
EUDAMEDClass IVD General (EU MDR)
Ref 50 Tests/kit（DR1078-1）Model 50 Tests/kit
Identity
- Trade Name
- Cardiac Troponin I（cTnI）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Cardiac Troponin I（cTnI）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 50 Tests/kit EUDAMED50 Tests/kit（DR1078-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969981189 EUDAMED
- Basic UDI-DI
- B-06974969981189 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
Cardiac Troponin I（cTnI）Detection Kit（Magnetic Solid Phase Chemiluminescent Imm… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…
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-06974969981189 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 718d93d6-2cc2-4a57-8c1b-38e9e0c93e4b 61 fields · synced Jul 24, 2026