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CLIA Helicobacter MONO IgA

by TestLine Clinical Diagnostics s.r.o. Czechia EUDAMED

Ref CL-HMA100 EMDN W0105010402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08595635310089 Basic UDI-DIDate24 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
CLIA Helicobacter MONO IgA
Model / Reference
CL-HMA100
Primary DI / UDI-DI
08595635310089
Basic UDI-DI
B-08595635310089
EMDN Code
W0105010402 H. pylori antibody assays
Device Class
Class IVD General
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000001803

Other devices from TestLine Clinical Diagnostics s.r.o.

See all devices from TestLine Clinical Diagnostics s.r.o. →

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 08595635310089|B-08595635310089 61 fields · synced 25 Oct 2026