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BeneCheck Uric Acid Control Solution

by General Life Biotechnology Co., Ltd. 6 variants

Ref BK-CSU12Model BX-M00D, BX-M000

Active European Union

CE IVDR CE IVDD

Valid until

18 Aug 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products 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 NumberIX 2029595-1 Date11 Sep 2026IssuedStatusActive expires 18 Aug 2030
European UnionCE/IVDD NumberB-BK-CSU12BN Basic UDI-DI Date3 Feb 2023RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IX 2029595-1 Active Supplemented

    Technical documentation EU IVDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Device Name
Uric acid control solution
BeneCheck Supreme Multi-Monitoring System
Model / Reference
BK-CSU12, BX-M00D, BX-M000
Primary DI / UDI-DI
D-BK-CSU12BN, 04711148330190
Basic UDI-DI
B-BK-CSU12BN, 471114833BXM00D2W
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class IVD devices for self-testing
Class C
EU 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.

See all devices from General Life Biotechnology Co., Ltd. →

Properties

  • Reagent YesEUDAMEDNoEUDAMED
  • Self Testing
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No