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AMA RUT Pro (48 in blocks)

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

Ref 0207Model AMA RUT Pro (48 in blocks) EMDN W0105090102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-4680008050207VJF6 Basic UDI-DIDate19 Sep 2025RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Helicobacter pylori AMA RAPID UREASE TEST (AMA RUT Pro)
Model / Reference
AMA RUT Pro (48 in blocks), 0207
Primary DI / UDI-DI
D-4680008050207VJF6
Basic UDI-DI
B-4680008050207VJF6
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

See all devices from «Association of Medicine and Analytics» Company Limited →

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 34e39813-6012-4c48-9167-e4ddff38a3ae 61 fields · synced 22 Oct 2026