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Helicobacter Pylori Test Kit (Urease)

by Zhuhai Lituo Biotechnology Co., Ltd. China EUDAMED

Ref LTH01-2

EMDN W0105010499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697223584HPTSW Basic UDI-DIDate24 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
LTH01-2
Primary DI / UDI-DI
16972235840045
Basic UDI-DI
697223584HPTSW
EMDN Code
W0105010499 H. pylori reagents - other
Device Class
Class B

Manufacturer details

EUDAMED SRN
CN-MF-000026852
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhuhai Lituo Biotechnology Co., Ltd.

See all devices from Zhuhai Lituo Biotechnology 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 625e7af5-0f5a-4eed-9f91-723869bdcfbc 61 fields · synced 22 Oct 2026