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Linksun Blood Glucose Monitoring System

by Bioland Technology Ltd. 3 variants

Ref G-430/G-425S-1Model G-427B/G-427BS,G-425-2/G-425-2S

Active European Union

CE IVDR

Valid until

16 Apr 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6939184630021BK Basic UDI-DI Date4 Jun 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Blood Glucose Monitoring System
Model / Reference
G-427B/G-427BS, G-425-2/G-425-2S, G-430/G-425S-1
Primary DI / UDI-DI
06939184632650, 06939184632643
Basic UDI-DI
6939184630021BK
Direct Marketing DI
06939184632650
06939184632643
EMDN Code
W0101060101, W010106010801, W0201060102
Device Class
Class C
EU market of registration
Ireland
Malta

Manufacturer details

EUDAMED SRN
CN-MF-000010625
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Bioland Technology Ltd.

See all devices from Bioland Technology Ltd. →

Properties

  • Reagent
  • Self Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No