Skip to content

Anti-Müllerian Hormone (AMH) Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. 3 variants

Ref IM4408208, IM4406208, IM4401208, IM4404208, IM4405208, IM4407208Model IM4402208 IM4403208 IM4406208 IM4407208

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-IM4408208K2 Basic UDI-DI Date22 May 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-IM4408208K2 Basic UDI-DI Date22 May 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Device Name
Anti-Müllerian Hormone (AMH) Chemiluminescent Immunoassay Kit
Model / Reference
IM4408208, IM4402208 IM4403208 IM4406208 IM4407208, IM4406208, IM4401208, IM4404208, IM4405208, IM4407208
Primary DI / UDI-DI
D-IM4408208K2, 06950617401025, D-IM4401208HH, D-IM4404208J6, D-IM4405208JD, 06950617401032
Basic UDI-DI
B-IM4408208K2, 69506174IM440208DE, B-IM4401208HH, B-IM4404208J6, B-IM4405208JD
Direct Marketing DI
06950617401025
06950617401032
EMDN Code
W0102050215 Anti-mullerian hormone
Device Class
Class IVD General
Class B
EU market of registration
Germany
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties

  • 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