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Helicobacter pylori Universal and CagA Type Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

by Sansure Biotech Inc. United States EUDAMED

Ref S3206E-48

EMDN W0105010499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06955792735422 Basic UDI-DIDate4 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Helicobacter pylori Universal and CagA Type Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Model / Reference
S3206E-48
Primary DI / UDI-DI
06955792735422
Basic UDI-DI
B-06955792735422
EMDN Code
W0105010499 H. pylori reagents - other
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000011392
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties & raw data

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

Sources (1)

  • EUDAMED d4100693-f5e9-467b-8c11-5703456a5131 61 fields · synced 22 Oct 2026