Skip to content

Access AMH Advanced (Reagent Pack)

by Immunotech SAS France EUDAMED

Ref C629997Model C62997

EMDN W0102050215

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number150995903AccAMHAdFB Basic UDI-DIDate7 Apr 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
C62997, C629997
Primary DI / UDI-DI
15099590740481
Basic UDI-DI
150995903AccAMHAdFB
EMDN Code
W0102050215 Anti-mullerian hormone
Device Class
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000011121

Properties & raw data

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

Sources (1)

  • EUDAMED 61764d0e-91d1-4c30-ace5-72a65942cd4d 61 fields · synced 22 Oct 2026