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Truenat Malaria Pv/Pf

by Molbio Diagnostics Limited 2 variants

Ref 601010050

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08908007989330 Basic UDI-DI 08908007989330UDI-DIDate1 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
601010050
Primary DI / UDI-DI
08908007989330
Basic UDI-DI
B-08908007989330
EMDN Code
W0105050209 Plasmodium (malaria)
Device Class
Class IVD General
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
IN-MF-000028386
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Molbio Diagnostics Limited

See all devices from Molbio Diagnostics Limited →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (5)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No