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SonoGo

by CHISON Medical Technologies Co., Ltd. FDA registration: China EUDAMED

Ref EBit 90 EMDN Z11040103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69451214EBitUC Basic UDI-DIDate17 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Digital Color Doppler Ultrasound System
Model / Reference
EBit 90
Primary DI / UDI-DI
06945121415880
Basic UDI-DI
69451214EBitUC
EMDN Code
Z11040103 Portable ultrasound scanners
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000021605
Authorised representative
R Sight B.V. NL-AR-000010445

Other devices from CHISON Medical Technologies Co., Ltd.

See all devices from CHISON Medical Technologies 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 06945121415880|69451214EBITUC 61 fields · synced 25 Oct 2026