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TAVI Analysis

by GE Medical Systems SCS France EUDAMED

Ref 5970994 EMDN Z11030692

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8406821BUG00082H8 Basic UDI-DIDate13 May 2022RegisteredStatusActive

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  • Withdrawn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

Model / Reference
5970994
Primary DI / UDI-DI
00195278923783
Basic UDI-DI
8406821BUG00082H8
Direct Marketing DI
00195278923783
EMDN Code
Z11030692 Computed tomographs (CT) - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000000687

Other devices from GE Medical Systems SCS

See all devices from GE Medical Systems SCS →

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 390ba04b-7435-4abf-bc68-1ec41ffe59a4 61 fields · synced 23 Oct 2026