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Ora-3D

by Vigilant Biosciences, Inc. United States EUDAMED

Ref 9000006

EMDN W0102160299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00860000930949 Basic UDI-DIDate20 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
9000006
Primary DI / UDI-DI
00860000930949
Basic UDI-DI
B-00860000930949
EMDN Code
W0102160299 Tumour marker rt & poc - other
Device Class
Class IVD General
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
  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 0fe4c9a3-0480-40e0-adc4-0df201e05e1b 61 fields · synced 23 Oct 2026