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AMA RUT Reader

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

Ref 0204Model AMA RUT Reader

EMDN W0201069080

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4680008050200V4 Basic UDI-DIDate29 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Helicobacter pylori AMA RAPID UREASE TEST (AMA RUT Reader)
Model / Reference
AMA RUT Reader, 0204
Primary DI / UDI-DI
14680008050103
Basic UDI-DI
4680008050200V4
EMDN Code
W0201069080 Various rapid test chemistry / immunochemistry instruments - hardware accessories
Device Class
Class A
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
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 5fd7f8f3-9c9f-4d1e-8285-3487c0230926 61 fields · synced 22 Oct 2026