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TDL Urinalysis Collection Kit

by REAL Digital International Ltd United Kingdom EUDAMED

Ref KT385

EMDN W05010299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number50567516MDTF0039PB Basic UDI-DIDate18 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Urinalysis Collection Kit
Model / Reference
KT385
Primary DI / UDI-DI
05056751600247
Basic UDI-DI
50567516MDTF0039PB
Direct Marketing DI
05056751600247
EMDN Code
W05010299 Urine 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 & 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 (1)

  • EUDAMED 8ab5b7b3-34a0-42a5-902e-04bd2f15cf36 61 fields · synced 23 Oct 2026