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One Step H.Pylori Serum/Plasma Test

by Guangzhou Wondfo Biotech Co., Ltd. EUDAMED

Active European Union

Ref W038P0043

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-W038P0043N8 Basic UDI-DIDate20 Oct 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  • Withdrawn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

Device Name
One Step H.Pylori Serum/Plasma Test
Model / Reference
W038P0043
Primary DI / UDI-DI
D-W038P0043N8
Basic UDI-DI
B-W038P0043N8
EMDN Code
W0105010402 H. pylori antibody assays
Device Class
Class IVD General
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000000689
Authorised representative
QbD RepS BV BE-AR-000000040

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Properties

Show properties
  • 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