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Linksun Blood Glucose Monitoring System

by Bioland Technology Ltd. 3 variants

Ref G-426/G-425S-1Model G-427B/G-427BS,G-425-2/G-425-2S

Active European Union and United States

CE IVDR 510(k)

Valid until

16 Apr 2030

CE IVDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

510(k) K191657↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number6939184630021BK Basic UDI-DI Date4 Jun 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK191657 Date20 Mar 2020IssuedStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Device Name
Blood Glucose Monitoring System
Model / Reference
G-427B/G-427BS, G-425-2/G-425-2S, G-426/G-425S-1
Primary DI / UDI-DI
06939184632636, 06939184632629
Basic UDI-DI
6939184630021BK
Direct Marketing DI
06939184632636
06939184632629
EMDN Code
W0101060101, W010106010801, W0201060102
Device Class
Class C
EU market of registration
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