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Anti-Endomysium Antibodies (Aea)

by Biosystems S.A. Spain EUDAMED

Ref 44715

EMDN W0102100603

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08435287147155 Basic UDI-DIDate22 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Anti-Endomysium Antibodies (Aea)
Model / Reference
44715
Primary DI / UDI-DI
08435287147155
Basic UDI-DI
B-08435287147155
EMDN Code
W0102100603 Antibodies to endomysial autoantigenes
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000231

Other devices from Biosystems S.A.

See all devices from Biosystems S.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 3ea62e3d-c29b-420b-956b-c479eeba9384 61 fields · synced 22 Oct 2026