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SIBIONICS GS1 Continuous Glucose Monitoring System

by Shenzhen SiSensing Co., Ltd. China EUDAMED

Ref GS1

EMDN Z1204011585

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697283164CGMGS1LL Basic UDI-DIDate22 Jan 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
GS1
Primary DI / UDI-DI
06972831641094
Basic UDI-DI
697283164CGMGS1LL
EMDN Code
Z1204011585 Invasive blood sugar monitoring systems, single–use sensors
Device Class
Class IIb
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000017945
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen SiSensing Co., Ltd.

See all devices from Shenzhen SiSensing Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Measuring Function
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED addff7d6-c995-4512-8b99-0f283b26051d 61 fields · synced 22 Oct 2026