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Tigsun AMH Antigen Rapid Test (FIA)

by Beijing Tigsun Diagnostics Co., Ltd. China EUDAMED

Model 10 tests EMDN W0102050215

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973642381599 Basic UDI-DIDate14 May 2025RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Tigsun AMH Antigen Rapid Test (FIA)
Model / Reference
10 tests
Primary DI / UDI-DI
06973642381599
Basic UDI-DI
B-06973642381599
EMDN Code
W0102050215 Anti-mullerian hormone
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000034480
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Beijing Tigsun Diagnostics Co., Ltd.

See all devices from Beijing Tigsun Diagnostics Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED da6d718a-be5f-4e31-8fcd-e202ba9884bc 61 fields · synced 22 Oct 2026