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SIBIONICS GS3-R Continuous Glucose Monitoring System

by Shenzhen SiSensing Co., Ltd. 2 variants

Ref GS3-RModel GS3

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDR Number697283164CGMGS3LQ Basic UDI-DI Date20 Mar 2025RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
SIBIONICS GS3 Continuous Glucose Monitoring System
Model / Reference
GS3, GS3-R
Primary DI / UDI-DI
06972831642565, 06972831643166, 06972831643517, 06972831643234, 06972831643746, 06972831644019, 06972831644002
Basic UDI-DI
697283164CGMGS3LQ
EMDN Code
Z1204011585 Invasive blood sugar monitoring systems, single–use sensors
Device Class
Class IIb
EU market of registration
Greece
Germany

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

  • 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