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HELIC ABT Reader indicator tube kit (50 pcs)

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

Ref 0106Model HELIC ABT Reader indicator tube kit (50 pcs) EMDN W0105090102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-4680008050106VBE6 Basic UDI-DIDate29 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  • Withdrawn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

Model / Reference
HELIC ABT Reader indicator tube kit (50 pcs), 0106
Primary DI / UDI-DI
D-4680008050106VBE6
Basic UDI-DI
B-4680008050106VBE6
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 fd295d63-2208-4262-982b-ef8ba2fbf3d9 61 fields · synced 22 Oct 2026