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Anti-Mullerian hormone (AMH)Determination Kit (Chemiluminescence Immunoassay)

by Shenzhen Channel Biotechnology Co., Ltd. China EUDAMED

Ref CR031EU01Model 10 Tests/Kit or 20 Tests/Kit

EMDN W0102050215

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976968300459 Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
10 Tests/Kit or 20 Tests/Kit, CR031EU01
Primary DI / UDI-DI
06976968300459
Basic UDI-DI
B-06976968300459
EMDN Code
W0102050215 Anti-mullerian hormone
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000053778
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 5ecd5e20-de37-49c2-bd6e-a9f140028d0f 61 fields · synced 22 Oct 2026