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Fibrinogen (Fb)Test Kit (Immunoturbidimetric)
EUDAMEDClass IVD General (EU MDR)
Ref R1:18mL×4 R2:6mL×4(709)
Identity
- Trade Name
- Fibrinogen (Fb)Test Kit (Immunoturbidimetric) EUDAMED
- Device Name
- Fibrinogen (Fb)Test Kit (Immunoturbidimetric) EUDAMED
- Model / Reference
- R1:18mL×4 R2:6mL×4(709) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674869658 EUDAMED
- Basic UDI-DI
- B-06971674869658 EUDAMED
- EMDN Code
- W0103020201 FIBRINOGEN ASSAYS (FACTOR I) 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
Fibrinogen (Fb)Test Kit (Immunoturbidimetric) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06971674869658 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED c3269195-53a6-4815-9c3d-1618f740abeb 61 fields · synced Aug 2, 2026