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Capillary Blood Collection Kit (SST)

by REAL Digital International Ltd

Ref KT353/MEDE, KT355/HCA

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number50567516MDTF0037P7 Basic UDI-DI Date15 Feb 2024RegisteredStatusActive

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  • Withdrawn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

Trade Name
Capillary Blood Collection Kit (SST)
Capillary Blood Collection Kit (SST & EDTA)
Device Name
TDL Capillary Blood Collection Kit
Model / Reference
KT353/MEDE, KT355/HCA
Primary DI / UDI-DI
05056751602036, 05056751601510
Basic UDI-DI
50567516MDTF0037P7
EMDN Code
W0501010299 Capillary blood collection devices - other
Device Class
Class A
EU 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

  • 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