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sST2 Test (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref 5J12C1-25-EU, 5J12C1-50-EU
Identity
- Trade Name
- sST2 Test (FIA) EUDAMED
- Device Name
- sST2 Test (FIA) EUDAMED
- Model / Reference
- 5J12C1-25-EU, 5J12C1-50-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5J12C1XL EUDAMED
- Basic UDI-DI
- B-5J12C1XL EUDAMED
- EMDN Code
- W0102160799 CARDIAC MARKERS - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
sST2 Test (FIA) by Xiamen Boson Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-5J12C1XL | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001096
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 30d45f7c-8145-4bb7-b41a-d17daf34c11e 61 fields · synced Jun 18, 2026
- EUDAMED 30d45f7c-8145-4bb7-b41a-d17daf34c11e-1 61 fields · synced Jun 10, 2026