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Sonicaid

by ArjoHuntleigh AB Sweden EUDAMED

Ref ACC-OBS-032Model ACC-OBS-021

EMDN Z12080199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5060693520457WQ Basic UDI-DIDate10 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
FM800 Encore Fecg - Eziplug
Model / Reference
ACC-OBS-021, ACC-OBS-032
Primary DI / UDI-DI
05051968030825
Basic UDI-DI
5060693520457WQ
EMDN Code
Z12080199 Prenatal diagnostic instruments - other
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
SE-MF-000000696

Other devices from Arjohuntleigh AB

See all devices from Arjohuntleigh AB →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 5799c640-564f-4bec-9c69-ecb26fb96b61 61 fields · synced 24 Oct 2026