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Strep B Rapid Test Cassette

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

Ref ISB-R502 EMDN W0105090104

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ISB-R502FT Basic UDI-DIDate14 Jul 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  • Withdrawn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 24 Oct 2026

Model / Reference
ISB-R502
Primary DI / UDI-DI
D-ISB-R502FT
Basic UDI-DI
B-ISB-R502FT
EMDN Code
W0105090104 Strep. b - rt & poc
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

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

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
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-ISB-R502FT|B-ISB-R502FT 61 fields · synced 24 Oct 2026