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H. pylori Antigen Rapid Test

by Shanghai Zymetas Medtech Co., Ltd China EUDAMED

Ref 50 test EMDN W01021699

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977412420792 Basic UDI-DIDate13 Jun 2024RegisteredStatusActive

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  • Withdrawn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 23 Oct 2026

Device Name
H. pylori Antigen Rapid Test
Model / Reference
50 test
Primary DI / UDI-DI
06977412420792
Basic UDI-DI
B-06977412420792
EMDN Code
W01021699 Rapid tests & point of care - immunochemistry - other
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000041858
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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 e8118fe8-ae23-4946-9b3d-2378fa6020f4 61 fields · synced 23 Oct 2026