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eBketolife blood ketone test strip

by Visgeneer Inc. EUDAMED

Active European Union

Ref 1320551Model LK-01

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04712558761062 Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
eBketolife blood ketone test strip
Model / Reference
LK-01, 1320551
Primary DI / UDI-DI
04712558761062
Basic UDI-DI
B-04712558761062
EMDN Code
W01010302 Bicarbonate
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000036547
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Microbial Substances
  • Self Testing
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Reagent: No
  • Companion Diagnostics: No
  • Surgical Instrument: No