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PlexPCR Flu/RSV/SARS-CoV-2

by SpeeDx Pty. Ltd. Australia EUDAMED

Ref 1703192Model 1.0 EMDN W0105070302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number9352224017031BNA Basic UDI-DIDate12 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
1.0, 1703192
Primary DI / UDI-DI
09352224001365
Basic UDI-DI
9352224017031BNA
Direct Marketing DI
09352224001365
EMDN Code
W0105070302 Other virus combinations - multiplex na reagents
Device Class
Class B
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
AU-MF-000016649
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Other devices from SpeeDx Pty. Ltd.

See all devices from SpeeDx Pty. Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • New Device
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

Sources (1)

  • EUDAMED 0d43c545-f769-4eb4-8729-fbbe1b3c5730 61 fields · synced 23 Oct 2026