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Venue Advanced

by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC United States EUDAMED

Ref Venue Advanced R7W EMDN Z11040101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08406821BUG006537K Basic UDI-DIDate3 Aug 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  • Withdrawn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 23 Oct 2026

Device Name
Venue Premier, Venue Advanced, Venue Focus
Model / Reference
Venue Advanced R7W
Primary DI / UDI-DI
00198953135143
Basic UDI-DI
08406821BUG006537K
Direct Marketing DI
00198953135143
EMDN Code
Z11040101 Internal ultrasound scanners
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000016119
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from GE Medical Systems Ultrasound and Primary Care Diagnostics LLC

See all devices from GE Medical Systems Ultrasound and Primary Care Diagnostics LLC →

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 47648e79-0eb7-4e2b-a523-6d63f921093c 61 fields · synced 23 Oct 2026