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Instara-G1

by Teljane Medical Technology (Suzhou) Co., Ltd. 10 variants

Ref IIbModel TX-14, TX-21

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69762300500446Y Basic UDI-DI 06976230050464UDI-DIDate13 Aug 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  • Withdrawn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
Model / Reference
TX-14, TX-21, IIb
Primary DI / UDI-DI
06976230050464
Basic UDI-DI
69762300500446Y
Direct Marketing DI
06976230050464
EMDN Code
Z1204011502 Invasive blood sugar monitoring systems
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000040009
Authorised representative
TRANSMED GLOBAL CONSULTING, S.L. ES-AR-000044598

Other devices from Teljane Medical Technology (Suzhou) Co., Ltd.

See all devices from Teljane Medical Technology (Suzhou) 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