Skip to content

PixoTest HbA1c Test Kit

by iXensor Co., Ltd. Taiwan EUDAMED

Ref 1254Model CDM-D01

EMDN W0101060107

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04719872951254 Basic UDI-DIDate8 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CDM-D01, 1254
Primary DI / UDI-DI
04719872951254
Basic UDI-DI
B-04719872951254
EMDN Code
W0101060107 Hba1c test strips
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
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED a6cc46a4-16d2-44c1-ad40-44bc0c1f48d1 61 fields · synced 22 Oct 2026