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Revolution Apex Expert

by Ge Hangwei Medical Systems Co., Ltd. China EUDAMED

Ref Revolution Apex Expert EMDN Z11030607

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8406821BUG00213GX Basic UDI-DIDate14 Mar 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  • Withdrawn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 22 Oct 2026

Device Name
Revolution Apex Select
Model / Reference
Revolution Apex Expert
Primary DI / UDI-DI
00195278633149
Basic UDI-DI
8406821BUG00213GX
EMDN Code
Z11030607 Computed tomographs - 256 layers or more
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009292
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from Ge Hangwei Medical Systems Co., Ltd.

See all devices from Ge Hangwei Medical Systems Co., Ltd. →

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 f0d40f36-5f3e-47f2-a5b0-1b494f7e0936 61 fields · synced 22 Oct 2026