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BeneCheck Supreme Uric Acid Test Strip

by General Life Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref BK-SU1-25VModel BX-M00D, BX-M000

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471114833BXM00D2W Basic UDI-DIDate8 Mar 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IX 2029595-1 Supplemented

    Technical documentation EU IVDR

    Notified body
    TÜV Rheinland LGA Products GmbH 0197
    Issued
    11 Sep 2026
    Expires
    18 Aug 2030
    Reason
    Add device or group

Specification

EUDAMED

Device Name
BeneCheck Supreme Multi-Monitoring System
Model / Reference
BX-M00D, BX-M000, BK-SU1-25V
Primary DI / UDI-DI
04711148333122
Basic UDI-DI
471114833BXM00D2W
EMDN Code
W0101060199 Blood test strips (cc) - rapid tests and "point of care" - other
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000027109
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from General Life Biotechnology Co., Ltd.

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Properties

Show properties
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No