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ChainFor Plasmodium falciparum Detection qPCR Kit

EUDAMED

Class IVD General (EU MDR)

Ref CFP99

by Vitrosens Biotechnology Inc.

Identity

Trade Name
ChainFor Plasmodium falciparum Detection qPCR Kit EUDAMED
Device Name
Plasmodium falciparum Detection qPCR Kit EUDAMED
Model / Reference
CFP99 EUDAMED

Identifiers

Primary DI / UDI-DI
08683548257956 EUDAMED
Basic UDI-DI
B-08683548257956 EUDAMED
EMDN Code
W0104050202 PLASMODIUM FALCIPARUM 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

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

Yes

EUDAMED

Surgical Instrument

Yes

EUDAMED

ChainFor Plasmodium falciparum Detection qPCR Kit by Vitrosens Biotechnology Inc. — 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

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Manufacturer

EUDAMED SRN
TR-MF-000026452

Sources (1)

  • EUDAMED c7bcaddb-6bf5-4368-8ef5-57cd1eaf5cc1 61 fields · synced Jun 19, 2026