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LinX

by MicroTech Medical (Hangzhou) Co., Ltd. United States EUDAMED

Ref 1034-FMTL-086Model GX-01S；GX-02S

EMDN Z1204011585

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69585903Z1204011502GXSDM Basic UDI-DIDate14 Feb 2026RegisteredStatusActive

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
Continuous Glucose Monitoring System Sensor
Model / Reference
GX-01S；GX-02S, 1034-FMTL-086
Primary DI / UDI-DI
06958590331032
Basic UDI-DI
69585903Z1204011502GXSDM
Direct Marketing DI
06958590331032
EMDN Code
Z1204011585 Invasive blood sugar monitoring systems, single–use sensors
Device Class
Class IIb
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000001157
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Microtech Medical (Hangzhou) Co., Ltd.

See all devices from Microtech Medical (Hangzhou) 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 0ba8690c-0564-404f-b0b8-5780b72aeb3a 61 fields · synced 22 Oct 2026