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PixoTest POCT Analyzer

by iXensor Co., Ltd. Taiwan EUDAMED

Ref 0806, 1544Model POC-X01 EMDN W0201010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04719872950806 Basic UDI-DIDate8 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
POC-X01, 0806, 1544
Primary DI / UDI-DI
04719872950806, 04719872951544
Basic UDI-DI
B-04719872950806, B-04719872951544
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000026279
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from iXensor Co., Ltd.

See all devices from iXensor Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (2)

  • EUDAMED 8e918917-4320-4a18-965c-4bd3d1f7f5f4 61 fields · synced 22 Oct 2026
  • EUDAMED c1ece2b5-b529-4001-8632-d60833b9b684 61 fields · synced 18 May 2026