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ALCIS AMH Control

by Boditech Med Inc. EUDAMED

Active European Union

Ref ACCO-18Model ALCIS β-hCG Calibrator

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08806133061657 Basic UDI-DIDate20 Oct 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  • Withdrawn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
ALCIS β-hCG Calibrator
Model / Reference
ALCIS β-hCG Calibrator, ACCO-18
Primary DI / UDI-DI
08806133061657
Basic UDI-DI
B-08806133061657
EMDN Code
W0102152002 Hormone controls
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000011028
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

Show properties
  • 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