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AESKULISA® Borrelia-G

by Aesku.Diagnostics GmbH & Co. KG United States EUDAMED

Ref 3802 EMDN W0105010603

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04250289501699 Basic UDI-DIDate3 Sep 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  • Withdrawn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 25 Oct 2026

Model / Reference
3802
Primary DI / UDI-DI
04250289501699
Basic UDI-DI
B-04250289501699
EMDN Code
W0105010603 Lyme antibody igg
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000026925

Other devices from AESKU.DIAGNOSTICS GmbH&Co.KG

See all devices from AESKU.DIAGNOSTICS GmbH&Co.KG →

Properties & raw data

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

Sources (1)

  • EUDAMED 04250289501699|B-04250289501699 61 fields · synced 25 Oct 2026