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BeneCheck Total Cholesterol Test Strip

by General Life Biotechnology Co., Ltd. Taiwan EUDAMED

Ref BK-C2, BK-C1 EMDN W0101060102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-BK-C2SA Basic UDI-DIDate19 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Total Cholesterol Test Strip
Model / Reference
BK-C2, BK-C1
Primary DI / UDI-DI
D-BK-C2SA, D-BK-C1S8
Basic UDI-DI
B-BK-C2SA, B-BK-C1S8
EMDN Code
W0101060102 Cholesterol test strips
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
  • Surgical Instrument NoEUDAMEDYesEUDAMED
Other properties (5)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Companion Diagnostics: No

Sources (2)

  • EUDAMED 91b5ae79-b79e-4b4c-9909-48fda271645b 61 fields · synced 22 Oct 2026
  • EUDAMED D-BK-C1S8|B-BK-C1S8 61 fields · synced 17 May 2026