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Glunovo

by Infinovo Medical Co., Ltd China EUDAMED

Ref CP04010201Model SP3-WL-03

EMDN Z1204011585

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-16973018100172 Basic UDI-DIDate4 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sensors of Continuous Glucose Monitoring Systems
Model / Reference
SP3-WL-03, CP04010201
Primary DI / UDI-DI
16973018100172
Basic UDI-DI
B-16973018100172
EMDN Code
Z1204011585 Invasive blood sugar monitoring systems, single–use sensors
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000020571
Authorised representative
Llins Service & Consulting GmbH DE-AR-000009077

Other devices from Infinovo Medical Co., Ltd

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Measuring Function
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED e3690df7-2a46-43eb-872a-851306f7d155 61 fields · synced 24 Oct 2026