Skip to content

Apolipoprotein E Reagent Kit

by Hangzhou Aichek Medical Technology Co., Ltd. United States EUDAMED

Ref APOE6011Y, APOE6012Y, APOE6013Y, APOE6014Y, APOE6015Y, APOE6011N, APOE6012N, APOE6013N, APOE6014N, APOE6015N EMDN W0102010404

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-APOE601WG Basic UDI-DIDate8 May 2026RegisteredStatusActive

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  • Withdrawn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
APOE6011Y, APOE6012Y, APOE6013Y, APOE6014Y, APOE6015Y, APOE6011N, APOE6012N, APOE6013N, APOE6014N, APOE6015N
Primary DI / UDI-DI
D-APOE601WG
Basic UDI-DI
B-APOE601WG
EMDN Code
W0102010404 Apolipoprotein e sub-typing
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000028093
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Hangzhou Aichek Medical Technology Co., Ltd.

See all devices from Hangzhou Aichek Medical Technology 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 88080c46-99d0-490c-92ed-2df579841ee6-1 61 fields · synced 22 Oct 2026