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S. typhi Ag Rapid Test Cassette (Serum/Plasma/Feces)

by Healgen Scientific Limited Liability Company United States EUDAMED

Ref GCSAL(ST)-602a

EMDN W0105011001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-GCSAL(ST)-602aHGMQ Basic UDI-DIDate31 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
GCSAL(ST)-602a
Primary DI / UDI-DI
D-GCSAL(ST)-602aHGMQ, D-GCSAL(ST)-602aS7
Basic UDI-DI
B-GCSAL(ST)-602aHGMQ, B-GCSAL(ST)-602aS7
EMDN Code
W0105011001 Salmonella antigen detection
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent NoEUDAMEDYesEUDAMED
  • 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 (2)

  • EUDAMED 35e79d5b-3dba-4160-a483-b75b984ce33e 61 fields · synced 22 Oct 2026
  • EUDAMED D-GCSAL(ST)-602AS7|B-GCSAL(ST)-602AS7 61 fields · synced 17 Sep 2026