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Human sST2 (Soluble ST2) rapid test cassette (Rare earth nano fluorescence immu…
EUDAMEDClass IVD General (EU MDR)
Ref IF023
Identity
- Device Name
- Human sST2 (Soluble ST2) rapid test cassette (Rare earth nano fluorescence immunochromatography) EUDAMED
- Model / Reference
- IF023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323013358 EUDAMED
- Basic UDI-DI
- B-06974323013358 EUDAMED
- EMDN Code
- W01021314 ST2 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
Human sST2 (Soluble ST2) rapid test cassette (Rare earth nano fluorescence immu… 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-06974323013358 | 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 7bdc02ed-4d76-49b1-b36e-179dfe60447a 61 fields · synced Jun 18, 2026