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SOMATOM X.cite

by Siemens Shanghai Medical Equipment Ltd.

Ref 11501200Model SOMATOM CT-Scanner_SHA NH

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686900124UN Basic UDI-DI 04056869295541UDI-DIDate26 May 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number04056869295541 UDI-DI Date30 Nov 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Full-body CT system
Device Name
SOMATOM CT-Scanner_SHA NH
Model / Reference
SOMATOM CT-Scanner_SHA NH, 11501200
Primary DI / UDI-DI
04056869295541
Basic UDI-DI
0405686900124UN
510(k) Number
FDA Product Code
JAK
EMDN Code
Z11030606 Computed tomographs - 128 layers or more but less than 256 layers
GMDN Term
Full-body CT system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1750
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000013434
Authorised representative
Siemens Healthcare GmbH DE-AR-000011241

Other devices from Siemens Shanghai, Medical Equipment Ltd.

See all devices from Siemens Shanghai, Medical Equipment Ltd. →

Properties

  • Serial Number

Other properties (23)

  • Sterile: No
  • Single Use: 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No