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AESKUCARE® Gluten Related Disorders IgA

by Aesku.Diagnostics GmbH & Co. KG EUDAMED

Active European Union

Ref 860001

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04250289511599 Basic UDI-DIDate28 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  • Withdrawn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

Device Name
AESKUCARE® Gluten Related Disorders
Model / Reference
860001
Primary DI / UDI-DI
04250289511599
Basic UDI-DI
B-04250289511599
EMDN Code
W0102010101 Immunoglobulin a
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000026925

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Properties

  • Animal Tissues
  • Microbial Substances
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No