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HBsAg Rapid Test Cassette

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

Ref IHBSG-402 EMDN W0105090201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936983122955 Basic UDI-DIDate20 Sep 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
IHBSG-402
Primary DI / UDI-DI
06936983122955, 06936983122986, 06936983106023, 06936983106016
Basic UDI-DI
B-06936983122955, B-06936983122986, B-06936983106023, B-06936983106016
EMDN Code
W0105090201 Hbsag - rt & poc
Device Class
Class IVD Annex II List A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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

See all devices from Hangzhou Alltest Biotech.Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (4)

  • EUDAMED 985cc7dd-1ce9-4cd9-b37e-b2ae690720a8 61 fields · synced 22 Oct 2026
  • EUDAMED 06936983122986|B-06936983122986 61 fields · synced 16 May 2026
  • EUDAMED 06936983106023|B-06936983106023 61 fields · synced 17 May 2026
  • EUDAMED 06936983106016|B-06936983106016 61 fields · synced 19 May 2026