Skip to content

GDH Glucose control solution

by Leison Biotech Co., Ltd. Taiwan EUDAMED

Ref N/AModel GDH

EMDN W010106010801

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-471987421CSYDLT Basic UDI-DIDate21 May 2026RegisteredStatusActive

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

Device Name
Glucose control solution (Low, Normal, High)
Model / Reference
GDH, N/A
Primary DI / UDI-DI
D-471987421CSYDLT
Basic UDI-DI
B-471987421CSYDLT
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class IVD devices for self-testing
Market of Registration
France

Manufacturer details

EUDAMED SRN
TW-MF-000026417
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Leison Biotech Co., Ltd.

  • Ap-10

    IVD for self-testing

  • Ap-10

    IVD for self-testing

  • Ap-10

    IVD for self-testing

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 2272fd54-4c45-4442-abc5-90e621773691 61 fields · synced 22 Oct 2026