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Wellion

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

Ref WELL19-S00PDAMMModel G7-P02

EMDN Z1204011599

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69585903Z120401CGMPDAKS Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Continuous Glucose Monitoring System PDA
Model / Reference
G7-P02, WELL19-S00PDAMM
Primary DI / UDI-DI
06958590306177
Basic UDI-DI
69585903Z120401CGMPDAKS
EMDN Code
Z1204011599 Blood sugar monitoring systems - other
Device Class
Class IIb
Market of Registration
Austria

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
  • Measuring Function
Other properties (12)
  • Sterile: No
  • 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 06958590306177|69585903Z120401CGMPDAKS 61 fields · synced 25 Oct 2026