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Access AMH Calibrators

by Immunotech SAS France EUDAMED

Ref B13128 EMDN W0102152299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number150995903AccAMHCal43 Basic UDI-DIDate2 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
B13128
Primary DI / UDI-DI
15099590665166
Basic UDI-DI
150995903AccAMHCal43
EMDN Code
W0102152299 Standards and calibrators - immunochemistry - other
Device Class
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000011121

Other devices from Immunotech SAS

See all devices from Immunotech SAS →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 531a57ee-755e-4fc5-9ef3-580b6349f81c 61 fields · synced 22 Oct 2026