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OmniLab

by Oacp Ie Ltd EUDAMED

Active European Union

Ref ED-209

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-5539154038ED-209T42K Basic UDI-DIDate5 Mar 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  • Withdrawn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

Device Name
OmniLab
Model / Reference
ED-209
Primary DI / UDI-DI
D-5539154038ED-209T42K
Basic UDI-DI
B-5539154038ED-209T42K
EMDN Code
W02050199 Nucleic acid testing instruments except micro-arrays - other
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IE-MF-000003506

Other devices from Oacp Ie Ltd

See all devices from Oacp Ie Ltd →

Properties

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