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OraFusion Software

by Vigilant Biosciences, Inc. United States EUDAMED

Ref 4000005

EMDN W0201069082

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number086000093094000005S5 Basic UDI-DIDate1 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
4000005
Primary DI / UDI-DI
00850050841005
Basic UDI-DI
086000093094000005S5
EMDN Code
W0201069082 Various rapid test chemistry / immunochemistry instruments - software accessories
Device Class
Class A
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000013534
Authorised representative
Vigilant Biosciences GmbH DE-AR-000028648

Other devices from Vigilant Biosciences, Inc.

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 3e93abc2-5604-48d9-a54f-048eb67f10ab 61 fields · synced 22 Oct 2026