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Optima CT660

by GE Healthcare Japan Corporation

Ref Optima CT660

Optima CT660 is a medical device (EU MDD Class IIb; EMDN category computed tomographs - 128 layers or more but less than 256 layers) made by GE Healthcare Japan Corporation, registered in EUDAMED on 26 May 2026 (Basic UDI-DI B-OptimaCT660WA), active as of 22 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-OptimaCT660WA Basic UDI-DI D-OptimaCT660WAUDI-DIDate26 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
Optima CT660
Primary DI / UDI-DI
D-OptimaCT660WA
Basic UDI-DI
B-OptimaCT660WA
EMDN code
Z11030606 Computed tomographs - 128 layers or more but less than 256 layers
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
France

Manufacturer details

EUDAMED SRN
JP-MF-000009291
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS.

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Properties

  • Measuring function
Other properties (11, all answered No)