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HP Ag H.pylori Antigen Rapid Test

by Shanghai Chemtron Biotech Co., Ltd. China EUDAMED

Ref 8022 EMDN W0105090102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number693869768022RS Basic UDI-DIDate21 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
8022
Primary DI / UDI-DI
06977775224211
Basic UDI-DI
693869768022RS
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class B
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000018072
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Shanghai Chemtron Biotech Co., Ltd.

See all devices from Shanghai Chemtron Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06977775224211|693869768022RS 61 fields · synced 24 Oct 2026