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SH24 Specimen Collection Kit

by SH24 Digital Ltd 23 variants

Ref Target

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5065019661CollectKitNT Basic UDI-DI 05065019661555UDI-DIDate17 Jun 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  • Withdrawn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
Target
Primary DI / UDI-DI
05065019661555
Basic UDI-DI
5065019661CollectKitNT
Direct Marketing DI
05065019661555
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
UK-MF-000048864
Authorised representative
CS Life Sciences Europe Ltd IE-AR-000004113

Other devices from SH24 Digital Ltd

See all devices from SH24 Digital Ltd →

Properties

  • Self Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No