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One Step cTnT rapid test cassette (Rare earth nano fluorescence immunochromatog…
EUDAMEDClass IVD General (EU MDR)
Ref IF035
Identity
- Device Name
- One Step cTnT rapid test cassette (Rare earth nano fluorescence immunochromatography) EUDAMED
- Model / Reference
- IF035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323013631 EUDAMED
- Basic UDI-DI
- B-06974323013631 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
One Step cTnT rapid test cassette (Rare earth nano fluorescence immunochromatog… by Beijing Applied Biological Technologies 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-06974323013631 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 4fe774ae-2d51-4f92-904c-a57bfa859e66 61 fields · synced Jun 19, 2026