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STANDARD™ Q HCV Ab Test

by SD Biosensor Inc. 2 variants

Ref 09HCV41DModel QHCV01B

Active European Union

CE IVDR

Valid until

2 Feb 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

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/IVDR Number88001117IPDA02QA07ZE Basic UDI-DI Date1 Oct 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 075369 0073 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    29 Sep 2026
    Expires
    2 Feb 2031
    Reason
    Other

Coverage

1 jurisdiction

NorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaRomaniaPortugalSpainItalyTürkiyeGreeceMalta
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

EU market availability

Made available in 27 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 28 May 2026
  • Belgium since 28 May 2026
  • Czechia since 28 May 2026
  • Denmark since 28 May 2026
  • Estonia since 28 May 2026
  • Finland since 28 May 2026
  • France since 28 May 2026
  • Germany since 28 May 2026
  • Greece since 28 May 2026
  • Iceland since 28 May 2026
  • Ireland since 28 May 2026
  • Italy since 28 May 2026
  • Latvia since 28 May 2026
  • Liechtenstein since 28 May 2026
  • Lithuania since 28 May 2026
  • Luxembourg since 28 May 2026
  • Malta since 28 May 2026
  • Netherlands since 28 May 2026
  • Northern Ireland since 28 May 2026
  • Norway since 28 May 2026
  • Poland since 28 May 2026
  • Portugal since 28 May 2026
  • Romania since 28 May 2026
  • Slovakia since 28 May 2026
  • Spain since 28 May 2026
  • Sweden since 28 May 2026
  • Türkiye since 28 May 2026

Last checked 23 Oct 2026.

Specification

EUDAMED

Model / Reference
QHCV01B, 09HCV41D
Primary DI / UDI-DI
08800111723957, 08800111723926, 08800111723940, 08800111723933
Basic UDI-DI
88001117IPDA02QA07ZE
EMDN Code
W0105090202 Hcv antibody -rt & poc
Device Class
Class D
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000009168
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No