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Single Site Swab Sample Collection Kit (Vaginal)

by Concepta Diagnostics EUDAMED

Active European Union

Ref T11000

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506075735T11000SC 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  • Withdrawn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
Single Site Swab Sample Collection Kit (Vaginal) (BOD)
Model / Reference
T11000
Primary DI / UDI-DI
05060757350921
Basic UDI-DI
506075735T11000SC
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 a vaginal swab sample to be performed at home. This sample is then returned to a laboratory and analysed against a variety of biomarkers.

Manufacturer details

EUDAMED SRN
GB-PR-000033063

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Properties

Show properties
Other properties (1)
  • Sterile: No