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Three Site Swab Sample Collection Kit (Vaginal/Rectal/Throat)

by Concepta Diagnostics EUDAMED

Active European Union

Ref T13000

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506075735T13000SS Basic UDI-DIDate7 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Three Site Swab Sample Collection Kit (Vaginal/Rectal/Throat) (BOD)
Model / Reference
T13000
Primary DI / UDI-DI
05060757350945
Basic UDI-DI
506075735T13000SS
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class I
Medical Purpose
This self-test kit is designed for adults (aged 18 and over) for the collection of vaginal, throat and rectal swab samples to be performed at home. These samples are then returned to a laboratory and analysed against a variety of biomarkers.

Manufacturer details

EUDAMED SRN
GB-PR-000033063

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Properties

Other properties (1)

  • Sterile: No