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HCT Extended

by R&D Systems, Inc. United States EUDAMED

Ref 0EH400TA3 EMDN W0103010503

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00815762023682 Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Hct
Model / Reference
0EH400TA3
Primary DI / UDI-DI
00815762023682
Basic UDI-DI
B-00815762023682
EMDN Code
W0103010503 Multilevel blood controls
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000024485
Authorised representative
BIO-TECHNE SAS FR-AR-000011963

Other devices from R&D Systems, Inc.

See all devices from R&D Systems, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
Other properties (9)
  • Sterile: 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 bb5c2b2d-8e05-4605-8fa8-2af72a858c4b 61 fields · synced 22 Oct 2026