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AMA RUT Expert

by «Association of Medicine and Analytics» Company Limited Russia EUDAMED

Ref 0205Model AMA RUT Expert

EMDN W0105090102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-4680008050205VEEJ Basic UDI-DIDate19 Sep 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

Device Name
Helicobacter pylori AMA RAPID UREASE TEST (AMA RUT Expert)
Model / Reference
AMA RUT Expert, 0205
Primary DI / UDI-DI
D-4680008050205VEEJ
Basic UDI-DI
B-4680008050205VEEJ
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class IVD General
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
RU-MF-000036645
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from «Association of Medicine and Analytics» Company Limited

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Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 6c579da0-7295-47d5-b72d-94aaf55d2eb4 61 fields · synced 22 Oct 2026