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Diagnostic Kit for Helicobacter pylori antigen (Colloidal Gold)

by Nantong EgensBiotechnology Co., Ltd.

Ref HP-Ag501601 HP-Ag251602Model HP-Ag strip cassette

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-693757991602QG Basic UDI-DI D-693757991602QGUDI-DIDate11 Sep 2023RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Model / Reference
HP-Ag strip cassette, HP-Ag501601 HP-Ag251602
Primary DI / UDI-DI
D-693757991602QG
Basic UDI-DI
B-693757991602QG
EMDN Code
W0105010401 H. pylori antigen detection
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
CN-MF-000021561
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Nantong EgensBiotechnology Co., Ltd.

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Properties

  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No