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MyoSPECT

by GE Medical Systems Israel, Functional Imaging Israel EUDAMED

Ref H3912AAModel MyoSPECT

EMDN Z11020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-IL-MF-000003062WY Basic UDI-DIDate11 Oct 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
MyoSPECT, H3912AA
Primary DI / UDI-DI
D-IL-MF-000003062WY
Basic UDI-DI
B-IL-MF-000003062WY
EMDN Code
Z11020101 Mobile gamma cameras
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
IL-MF-000003062
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Properties & raw data

Show properties, registry sources and raw records
  • Reprocessed
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 574bb537-7c0a-4cca-9b5c-d079e7d704ba 61 fields · synced 22 Oct 2026