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BeneCheck β-Ketone Control Solution

by General Life Biotechnology Co., Ltd. Taiwan EUDAMED

Ref BK-CSK12

EMDN W010106010801

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-BK-CSK12A4 Basic UDI-DIDate3 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
β-ketone control solution
Model / Reference
BK-CSK12
Primary DI / UDI-DI
D-BK-CSK12A4
Basic UDI-DI
B-BK-CSK12A4
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class IVD devices for self-testing
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 & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 13423843-933e-45cd-a246-e0d7cf2537a0 61 fields · synced 24 Oct 2026