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LinX

by MicroTech Medical (Hangzhou) Co., Ltd. 7 variants

Ref 1034-FMTL-072Model GX-01S；GX-02S

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69585903Z1204011502GXSDM Basic UDI-DI 06958590309758UDI-DIDate14 Feb 2026RegisteredStatusActive

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  • Withdrawn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
Continuous Glucose Monitoring System Sensor
Model / Reference
GX-01S；GX-02S, 1034-FMTL-072
Primary DI / UDI-DI
06958590309758
Basic UDI-DI
69585903Z1204011502GXSDM
Direct Marketing DI
06958590309758
EMDN Code
Z1204011585 Invasive blood sugar monitoring systems, single–use sensors
Device Class
Class IIb
EU market of registration
Italy

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

  • 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