Skip to content

UTS Tube 5ml™

by Clinical Design Technologies Group Ltd

Ref UTSTT02

Active European Union

CE IVDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number506069102UTST5ml50W5 Basic UDI-DI 05060691020188UDI-DIDate20 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
UTSTT02
Primary DI / UDI-DI
05060691020188
Basic UDI-DI
506069102UTST5ml50W5
EMDN Code
W05010202 Urine collection, tubes
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
UK-MF-000057787
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Other devices from Clinical Design Technologies Group Ltd

Properties

  • Near-Patient Testing
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No