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PlexPCR RespiVirus (LC480)

by SpeeDx Pty. Ltd. Australia EUDAMED

Ref 99011Model 1.0

EMDN W02050192

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number9352224012010WA Basic UDI-DIDate21 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
PlexPCR RespiVirus
Model / Reference
1.0, 99011
Primary DI / UDI-DI
09352224001372
Basic UDI-DI
9352224012010WA
Direct Marketing DI
09352224001372
EMDN Code
W02050192 Nucleic acid testing instruments except micro-arrays - IVD medical device software
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
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 09352224001372|9352224012010WA 61 fields · synced 25 Oct 2026