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Procalcitonin (PCT) Test Kit (Latex Immunoturbidimetric)

EUDAMED

Class IVD General (EU MDR)

Ref R1:20mL×4 R2:5mL×4（709）Ref R1:20mL×1 R2:5mL×1（702）Ref Calibrator：1mL×1（91060）

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
Procalcitonin (PCT) Test Kit (Latex Immunoturbidimetric) EUDAMED
Device Name
Procalcitonin (PCT) Test Kit (Latex Immunoturbidimetric) EUDAMED
Model / Reference
R1:20mL×4 R2:5mL×4（709） EUDAMED
R1:20mL×1 R2:5mL×1（702） EUDAMED
Calibrator：1mL×1（91060） EUDAMED

Identifiers

Primary DI / UDI-DI
06971674869801 EUDAMED
06971674869818 EUDAMED
06971674868163 EUDAMED
Basic UDI-DI
B-06971674869801 EUDAMED
B-06971674869818 EUDAMED
B-06971674868163 EUDAMED
EMDN Code
W0102069013 PROCALCITONIN 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

Procalcitonin (PCT) Test Kit (Latex 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 afae70d8-dea0-442d-8f50-f76f53ff5068 61 fields · synced Oct 7, 2026
  • EUDAMED cfdc421a-bab4-408d-b361-389e574dceef 61 fields · synced May 18, 2026
  • EUDAMED d23636cc-3295-495b-8f55-cf28e42d74be 61 fields · synced May 19, 2026