Skip to content

OraTrust Oral Fluid Collection System

by Microgenics Corporation United States EUDAMED

Ref B40001764

EMDN W05019002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0884883XCDDFRREC93190QA Basic UDI-DIDate10 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
B40001764
Primary DI / UDI-DI
00884883009295
Basic UDI-DI
0884883XCDDFRREC93190QA
EMDN Code
W05019002 Saliva collection devices
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000030375
Authorised representative
B·R·A·H·M·S GmbH DE-AR-000026031

Other devices from Microgenics Corporation

See all devices from Microgenics Corporation →

Properties & raw data

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

Sources (1)

  • EUDAMED 00884883009295|0884883XCDDFRREC93190QA 61 fields · synced 25 Oct 2026