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STANDARD Q Malaria P.f/P.v Ag

by SD Biosensor Healthcare Pvt. Ltd.

Ref RK025-40

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDR, withdrawn

Ended

Withdrawn

Date not published (CE IVDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number890611647IPCA01QS01PH Basic UDI-DI 08906116470244UDI-DIDate4 Sep 2026RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Specification

EUDAMED

Device Name
STANDARD Q Malaria P.f/P.v Ag
Model / Reference
RK025-40
Primary DI / UDI-DI
08906116470244
Basic UDI-DI
890611647IPCA01QS01PH
Direct Marketing DI
08906116470244
EMDN Code
W0105090401 Plasmodium (malaria) - rt & poc
Device Class
Class C

Manufacturer details

EUDAMED SRN
IN-MF-000026102
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Properties

  • Professional Testing
  • Companion Diagnostics

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No
  • New Device: No