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HELIC ABT Reader

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

Ref 0105, 0109Model HELIC ABT Reader, HELIC ABT Reader indicator tube kit (30 pcs)

EMDN W0201069080

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number4680008050100UX Basic UDI-DIDate18 Sep 2025RegisteredStatusActive
European UnionCE/IVDR Number4680008050100UX Basic UDI-DIDate18 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
HELIC ABT Reader
HELIC ABT Reader indicator tube kit (30 pcs)
Device Name
HELIC Ammonia Breath Test (HELIC ABT Reader)
Model / Reference
HELIC ABT Reader, 0105, HELIC ABT Reader indicator tube kit (30 pcs), 0109
Primary DI / UDI-DI
14680008050219, D-4680008050109VHEZ
Basic UDI-DI
4680008050100UX, B-4680008050109VHEZ
EMDN Code
W0201069080, W0105090102
Device Class
Class A
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 (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 14e10a57-ae28-460c-aa05-a4b60e6dc9bf 61 fields · synced 22 Oct 2026
  • EUDAMED D-4680008050109VHEZ|B-4680008050109VHEZ 61 fields · synced 18 May 2026