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Godious

by Godius Co., Ltd South Korea EUDAMED

Ref GFUSUM-U10-EN (IFU)Model GODIUS U10

EMDN Z120610

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880031824GODIUSZ120610M4 Basic UDI-DIDate8 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Godius
Model / Reference
GODIUS U10, GFUSUM-U10-EN (IFU)
Primary DI / UDI-DI
08800318240004
Basic UDI-DI
880031824GODIUSZ120610M4
Direct Marketing DI
08800318240004
EMDN Code
Z120610 Ultrasound therapy equipment
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000049140
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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 e85aa540-43be-4e75-9124-c27f89ededce 61 fields · synced 22 Oct 2026