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Urine & Two Site Swab Sample Collection Kit (Rectal/Throat)

by Concepta Diagnostics

Ref T14000

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506075735T14000SZ Basic UDI-DI 05060757350952UDI-DIDate7 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Urine & Two Site Swab Sample Collection Kit (Rectal/Throat) (BOD)
Model / Reference
T14000
Primary DI / UDI-DI
05060757350952
Basic UDI-DI
506075735T14000SZ
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) to collect a urine sample and throat and rectal swab samples 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