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Urine Sample Collection Kit

by REAL Digital International Ltd United Kingdom EUDAMED

Ref KT90001, KT20003

EMDN W05010299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number50567516MDTF0045P6 Basic UDI-DIDate29 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Trade Name
Urine Sample Collection Kit
Sexual Health - Urine Sample Collection Kit
Device Name
RDi Sexual Health Collection Kits
Model / Reference
KT90001, KT20003
Primary DI / UDI-DI
05056751600551, 05056751600452
Basic UDI-DI
50567516MDTF0045P6, 50567516MDTF0043P2
Direct Marketing DI
05056751600452
EMDN Code
W05010299, W05019099
Device Class
Class A
Market of Registration
Northern Ireland
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 29212961-b010-4cdd-9a88-ad5951887f47 61 fields · synced 24 Oct 2026
  • EUDAMED 05056751600452|50567516MDTF0043P2 61 fields · synced 18 May 2026