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Holotype HLA 24/7 - Configuration A3 & CE v2

by Omixon Biocomputing Ltd. Hungary EUDAMED

Ref H58 EMDN W01030499

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05999565780227 Basic UDI-DIDate10 Jul 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
H58
Primary DI / UDI-DI
05999565780227
Basic UDI-DI
B-05999565780227
EMDN Code
W01030499 Tissue typing reagents - other
Device Class
Class IVD Annex II List B
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000003018

From the manufacturer

Manufacturer's product page: Holotype HLA™

Other devices from Omixon Biocomputing Ltd.

See all devices from Omixon Biocomputing Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED e1f83554-77e5-4de6-967e-4bf1b28d2a75 61 fields · synced 22 Oct 2026