Skip to content

Anti-Müllerian Hormone (AMH) Test Kit (Immunofluorescence)

by Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref 2220

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978198482202 Basic UDI-DIDate10 Apr 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  • Withdrawn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

Model / Reference
2220
Primary DI / UDI-DI
06978198482202
Basic UDI-DI
B-06978198482202
EMDN Code
W0102050215 Anti-mullerian hormone
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000046524
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.

See all devices from Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd. →

Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No