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Revolution Altitude Elite

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

Ref Revolution Altitude Elite EMDN Z11030606

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08406821BUG0060578 Basic UDI-DIDate3 Nov 2025RegisteredStatusActive

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  • Withdrawn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
Revolution Altitude Family
Model / Reference
Revolution Altitude Elite
Primary DI / UDI-DI
00198953018996
Basic UDI-DI
08406821BUG0060578
EMDN Code
Z11030606 Computed tomographs - 128 layers or more but less than 256 layers
Device Class
Class IIb
Market of Registration
Spain

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 f79585a6-c154-4e39-bcf7-e946768e4b99 61 fields · synced 23 Oct 2026