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Accu-Tell® H. pylori IgG/IgM/IgA Cassette(Whole Blood/Serum/Plasma)

by AccuBioTech Co., Ltd.

Ref ABT-IDT-B385Model Cassette

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970581430616 Basic UDI-DI 06970581430616UDI-DIDate6 Mar 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Accu-Tell® H. pylori IgG/IgM/IgA Cassette
Model / Reference
Cassette, ABT-IDT-B385
Primary DI / UDI-DI
06970581430616
Basic UDI-DI
B-06970581430616
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025172
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No