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HELIC ABT Reader indicator tube kit (1 pcs)

by «Association of Medicine and Analytics» Company Limited

Ref 0107Model HELIC ABT Reader indicator tube kit (1 pcs)

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-4680008050107VDEF Basic UDI-DI D-4680008050107VDEFUDI-DIDate29 Sep 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
HELIC ABT Reader indicator tube kit (1 pcs), 0107
Primary DI / UDI-DI
D-4680008050107VDEF
Basic UDI-DI
B-4680008050107VDEF
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class IVD General
EU market of registration
Finland

Manufacturer details

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

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Properties

  • 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