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Ketone Test Strips

by Beijing Lepu Medical Technology Co., Ltd. China EUDAMED

Ref GL0625Model KT S1101 GL0625

EMDN W0101060110

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06921807610275 Basic UDI-DIDate10 Jan 2024RegisteredStatusActive

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 22 Oct 2026

Model / Reference
KT S1101 GL0625, GL0625
Primary DI / UDI-DI
06921807610275
Basic UDI-DI
B-06921807610275
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
CN-MF-000033011
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Other devices from Beijing Lepu Medical Technology Co., Ltd.

See all devices from Beijing Lepu Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED ed62d3e4-15be-4137-a765-f74ead71c7e8 61 fields · synced 22 Oct 2026