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H.Pylori Antigen Test Kit

by Anhui Deepblue Medical Technology Co., Ltd EUDAMED

Active European Union

Ref HPAg1FEST-1Model Cassette Tube Strip

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberEU-TDA-FI-20642-800030-2025-1 Date9 Jun 2026IssuedStatusActive expires 21 Mar 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EU-TDA-FI-20642-800030-2025-1 Supplemented

    Technical documentation EU IVDR

    Notified body
    Notified body 3018
    Issued
    9 Jun 2026
    Expires
    21 Mar 2030
    Reason
    Add device or group

Specification

EUDAMED

Model / Reference
Cassette Tube Strip, HPAg1FEST-1
Primary DI / UDI-DI
06952062711643
Basic UDI-DI
69520627J016LB
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018785
Authorised representative
Mega Eurostar Sp. z o.o. PL-AR-000042730

Other devices from Anhui Deepblue Medical Technology Co., Ltd

See all devices from Anhui Deepblue Medical Technology Co., Ltd →

Properties

  • Animal Tissues
  • Self Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No