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RevoDx Sexually Transmitted Infections (STIs) Pathogen Detection Kit

by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. EUDAMED

Active European Union

Ref IP202229-12sl

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08684387210959 Basic UDI-DIDate6 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
IP202229-12sl
Primary DI / UDI-DI
08684387210959
Basic UDI-DI
B-08684387210959
EMDN Code
W0105070501 Stis / stds (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex na reagents
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000047330

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No