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SIBIONICS GS1 ECO Continuous Glucose Monitoring System - Sensor Applicator Kit

by Shenzhen SiSensing Co., Ltd. China EUDAMED

Ref GS1-P2

EMDN Z1204011585

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697283164CGMGS1P27H Basic UDI-DIDate20 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
SIBIONICS GS1 ECO Continuous Glucose Monitoring System
Model / Reference
GS1-P2
Primary DI / UDI-DI
06972831643210
Basic UDI-DI
697283164CGMGS1P27H
EMDN Code
Z1204011585 Invasive blood sugar monitoring systems, single–use sensors
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

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

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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 7c9d93d1-58bd-46cc-b565-be48f5c84c80 61 fields · synced 22 Oct 2026