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Discovery MI Gen2

by GE Medical Systems, LLC United States EUDAMED

Ref PCM-PET0009Model Discovery MI Gen2

EMDN Z11020301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8406821BUG00159HJ Basic UDI-DIDate7 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
Discovery MI Gen2, PCM-PET0009
Primary DI / UDI-DI
00198953194089
Basic UDI-DI
8406821BUG00159HJ
EMDN Code
Z11020301 CT/pet systems
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000018315
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from GE Medical Systems, LLC

See all devices from GE Medical Systems, 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 00198953194089|8406821BUG00159HJ 61 fields · synced 25 Oct 2026