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UU Tube

by Hangzhou New Horizon Health Technology Co., Ltd.

Ref /Model 1 test/ kit

Active European Union

CE IVDR

Valid until

8 Sep 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697198073020MW Basic UDI-DI 06971980730208UDI-DIDate1 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 818165 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    17 Aug 2026
    Expires
    8 Sep 2030
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Helicobacter Pylori Antigen Test (Latex Microspheres)
Model / Reference
1 test/ kit, /
Primary DI / UDI-DI
06971980730208
Basic UDI-DI
697198073020MW
EMDN Code
W0105010401 H. pylori antigen detection
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000027517
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Hangzhou New Horizon Health Technology Co., Ltd.

See all devices from Hangzhou New Horizon Health Technology Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Self Testing
  • Professional Testing

Other properties (7)

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