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preOx - HUT

by preOx.RS GmbH Germany EUDAMED

Ref 200.060, 200.101, 200.100Model Helicobacter Urease Test

EMDN W0105090102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04260702150120 Basic UDI-DIDate24 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Helicobacter Urease Test, 200.060, 200.101, 200.100
Primary DI / UDI-DI
04260702150120, 04260702150151, 04260702150144, 04260702150168
Basic UDI-DI
B-04260702150120, B-04260702150151, B-04260702150144, B-04260702150168
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class IVD General
Market of Registration
Germany
Luxembourg

Manufacturer details

EUDAMED SRN
DE-MF-000005017

Other devices from preOx.RS GmbH

See all devices from preOx.RS GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (4)

  • EUDAMED a8c07dfa-5fc6-4d1e-90b7-f15b66eb45e1 61 fields · synced 22 Oct 2026
  • EUDAMED 04260702150151|B-04260702150151 61 fields · synced 17 May 2026
  • EUDAMED 04260702150144|B-04260702150144 61 fields · synced 17 May 2026
  • EUDAMED 04260702150168|B-04260702150168 61 fields · synced 19 May 2026