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TDL Sexual Health Collection Kit

by REAL Digital International Ltd EUDAMED

Active European Union

Ref KT358

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number50567516MDTF0038P9 Basic UDI-DIDate27 Feb 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sexual Health Collection Kit
Model / Reference
KT358
Primary DI / UDI-DI
05056751600285
Basic UDI-DI
50567516MDTF0038P9
Direct Marketing DI
05056751600285
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000039088
Authorised representative
Casus Europe B.V. NL-AR-000037688

Other devices from REAL Digital International Ltd

See all devices from REAL Digital International Ltd →

Properties

Show properties
  • New Device
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No