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CHORUS HELICOBATER PYLORI Ag

by DIESSE Diagnostica Senese S.p.A Italy EUDAMED

Ref 81063Model CHORUSPAG EMDN W0105010401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number803389132CHORUSPAG007V Basic UDI-DIDate19 Jan 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  • Withdrawn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 22 Oct 2026

Model / Reference
CHORUSPAG, 81063
Primary DI / UDI-DI
08033891326968
Basic UDI-DI
803389132CHORUSPAG007V
EMDN Code
W0105010401 H. pylori antigen detection
Device Class
Class B
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000013311

Other devices from Diesse Diagnostica Senese S.P.A

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Properties & raw data

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

Sources (1)

  • EUDAMED 7bace96d-c053-4225-839a-37d2c5e196f4 61 fields · synced 22 Oct 2026