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Helicobacter pylori (HP) rapid urease test card (biochemical method)

by Shenzhen Sciarray Biotech Co., Ltd. China EUDAMED

Ref 20 tests/ kit

EMDN W0105010499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06975491761218 Basic UDI-DIDate7 Apr 2026RegisteredStatusActive

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 (HP) rapid urease test card (biochemical method)
Model / Reference
20 tests/ kit
Primary DI / UDI-DI
06975491761218
Basic UDI-DI
B-06975491761218
EMDN Code
W0105010499 H. pylori reagents - other
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000038307
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 2308a16d-a7eb-4fef-9841-c8b97b8c8350 61 fields · synced 22 Oct 2026