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SANcheck ABEL β-Ketone Test Strip

by General Life Biotechnology Co., Ltd. Taiwan EUDAMED

Ref BK-SK1 EMDN W0101060110

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-BK-SK19S 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  • Withdrawn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
β-Ketone Test Strip
Model / Reference
BK-SK1
Primary DI / UDI-DI
D-BK-SK19S
Basic UDI-DI
B-BK-SK19S
EMDN Code
W0101060110 Ketone test strips (β-hydroxybutyrate 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
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 7cd4a7bd-c220-440d-89af-29f337093dc0 61 fields · synced 22 Oct 2026