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Holotype HLA 96/7 – Configuration A & CE v2

by Omixon Biocomputing Ltd. EUDAMED

Active European Union

Ref H32.1

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05999565780678 Basic UDI-DIDate21 Sep 2022RegisteredStatusActive

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  • Withdrawn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

Model / Reference
H32.1
Primary DI / UDI-DI
05999565780678
Basic UDI-DI
B-05999565780678
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD Annex II List B
Market of Registration
France

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

Show properties
  • 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