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Cardiac Troponin I（cTnI）Detection Kit（Magnetic Solid Phase Chemiluminescent Imm…
EUDAMEDClass IVD General (EU MDR)
Ref 200 Tests/kit（DR1078-3）Model 200 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
- 200 Tests/kit EUDAMED200 Tests/kit（DR1078-3） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969982322 EUDAMED
- Basic UDI-DI
- B-06974969982322 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-06974969982322 | 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 245e79a5-019b-4d61-b992-f51830a751f0 61 fields · synced Jun 18, 2026