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PlexPCR Colour Compensation

by SpeeDx Pty. Ltd. Australia EUDAMED

Ref 90001Model 1.0

EMDN W0105080908

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number9352224090001YK Basic UDI-DIDate25 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
1.0, 90001
Primary DI / UDI-DI
09352224000030
Basic UDI-DI
9352224090001YK
Direct Marketing DI
09352224000030
EMDN Code
W0105080908 Standards and calibrators for all infections/ nat
Device Class
Class A
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
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 73c0c3b8-b385-4df2-94c2-3f85e7ca51fe 61 fields · synced 23 Oct 2026