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Continuous Glucose Monitoring System

by Syai Health Technology Pte. Ltd. 2 variants

Ref M8Model X1, M8

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 Number88850212601VJ Basic UDI-DI 08885021260129UDI-DIDate18 Oct 2024RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
X1, M8
Primary DI / UDI-DI
08885021260129
Basic UDI-DI
88850212601VJ
EMDN Code
Z1204011585 Invasive blood sugar monitoring systems, single–use sensors
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
SG-MF-000041645
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Syai Health Technology Pte. Ltd.

  • Syai

    Class IIb

  • Syai

    Class IIb

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