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Ferritin (Fet)Test Kit (Latex Enhanced Immunoturbidimetric)

EUDAMED

Class IVD General (EU MDR)

Ref R1:20mL×1 R2:10mL×1Model R1:20mL×1 R2:10mL×1（702）Ref Quality Control：1mL×1（92042）Ref Calibrator：0.5mL×5（91046）

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
Ferritin (Fet)Test Kit (Latex Enhanced Immunoturbidimetric) EUDAMED
Device Name
Ferritin (Fet)Test Kit (Latex Enhanced Immunoturbidimetric) EUDAMED
Model / Reference
R1:20mL×1 R2:10mL×1（702） EUDAMED
R1:20mL×1 R2:10mL×1 EUDAMED
Quality Control：1mL×1（92042） EUDAMED
Calibrator：0.5mL×5（91046） EUDAMED

Identifiers

Primary DI / UDI-DI
06971674869597 EUDAMED
06971674868477 EUDAMED
06971674868095 EUDAMED
Basic UDI-DI
B-06971674869597 EUDAMED
B-06971674868477 EUDAMED
B-06971674868095 EUDAMED
EMDN Code
W0102070102 FERRITIN 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

Ferritin (Fet)Test Kit (Latex Enhanced 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

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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 (3)

  • EUDAMED 1edab4e0-63f1-4e33-9ee8-c854e1dda0f6 61 fields · synced Oct 6, 2026
  • EUDAMED 8b673dcf-12a7-4ab9-b33a-0b6b8bfdeadb 61 fields · synced May 17, 2026
  • EUDAMED 67156c2b-8a8e-4790-aa1e-d683df39bb49 61 fields · synced May 18, 2026