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HAV IgM&Syphilis Combo Rapid Test

by Hangzhou Alltest Biotech.Co., Ltd. China EUDAMED

Ref IHAS-425 EMDN W0105090699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-IHAS-425(AT)HY Basic UDI-DIDate21 Sep 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
IHAS-425
Primary DI / UDI-DI
D-IHAS-425(AT)HY
Basic UDI-DI
B-IHAS-425(AT)HY
EMDN Code
W0105090699 Other multiple pathogens - rt & poc
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
VidaQuick Biotech S.L. ES-AR-000048138

Other devices from Hangzhou Alltest Biotech.Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED D-IHAS-425(AT)HY|B-IHAS-425(AT)HY 61 fields · synced 25 Oct 2026