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LOGIQ Fortis

by GE Ultrasound Korea, Ltd.

Ref LOGIQ Fortis R4R5_R6 mE UPG / 6003777Model LOGIQ Fortis

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8406821BUG00214GZ Basic UDI-DI 00198953198650UDI-DIDate16 Dec 2021RegisteredStatusActive

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  • Withdrawn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
LOGIQ Fortis
Model / Reference
LOGIQ Fortis, LOGIQ Fortis R4R5_R6 mE UPG / 6003777
Primary DI / UDI-DI
00198953198650
Basic UDI-DI
8406821BUG00214GZ
EMDN Code
Z11040101 Internal ultrasound scanners
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
KR-MF-000001860
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from GE Ultrasound Korea, Ltd.

See all devices from GE Ultrasound Korea, Ltd. →

Properties

  • 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