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Computed Tomography X-ray System

by Shanghai United Imaging Healthcare Co., Ltd. 6 variants

Ref 88006055Model uCT SiriuX

Computed Tomography X-ray System (88006055) is a Class IIb device made by Shanghai United Imaging Healthcare Co., Ltd., registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI 697157683153NE), active as of 24 Oct 2026.

Active European Union

CE MDR

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697157683153NE Basic UDI-DI 06971576831531UDI-DIDate21 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
uCT SiriuX, 88006055
Primary DI / UDI-DI
06971576831531
Basic UDI-DI
697157683153NE
EMDN code
Z11030607 Computed tomographs - 256 layers or more
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000008501
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE.

Other devices from Shanghai United Imaging Healthcare Co., Ltd.

See all devices from Shanghai United Imaging Healthcare Co., Ltd. →

Properties

  • Measuring function
Other properties (13, all answered No)