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Truenat CT/NG

by Molbio Diagnostics Limited 6 variants

Ref 601160050Model 601160005, 601160020, 601160025, 601160050, 601160100, 601160200

Active European Union

CE IVDR

Valid until

21 Aug 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

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/IVDR Number8908007989552CG Basic UDI-DI 08908007989576UDI-DIDate2 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
601160005, 601160020, 601160025, 601160050, 601160100, 601160200
Primary DI / UDI-DI
08908007989576
Basic UDI-DI
8908007989552CG
EMDN Code
W0105070501 Stis / stds (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex na reagents
Device Class
Class C
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 (6)

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