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Cios Select 11515055

by Siemens Shanghai Medical Equipment Ltd.

Ref 11515055Model MDR_01_IIb_SHA_ACDV_Cios Select

Cios Select 11515055 is a device classified as Class IIb in the EU and Class II in the US made by Siemens Shanghai Medical Equipment Ltd., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 0405686900121UG) and listed in FDA GUDID since 7 Jun 2023 (UDI-DI 04056869267197), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686900121UG Basic UDI-DI 04056869267197UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04056869267197 UDI-DI Date7 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0405686900121UG registered 23 Jun 2026 Active
  • FDA GUDID UDI-DI 04056869267197 listed 7 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04056869267197
  2. Registered EUDAMED 0405686900121UG

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  • Withdrawn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

Trade name
Cios Select
Generic name
Portable general-purpose fluoroscopic x-ray system, analogue
Device name
MDR_01_IIb_SHA_ACDV_Cios Select
Model / reference
11515055, MDR_01_IIb_SHA_ACDV_Cios Select
Primary DI / UDI-DI
04056869267197
Basic UDI-DI
0405686900121UG
FDA product code
OXO, OWB, JAA
EMDN code
Z11039017 Mobile radioscopic units
GMDN term
Portable general-purpose fluoroscopic x-ray system, analogue
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650
EU registration type
Standard device
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

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Portable general-purpose fluoroscopic x-ray system, analogue

Similar devices in this category

Other devices filed under MOBILE RADIOSCOPIC UNITS.

Other devices from Siemens Shanghai Medical Equipment Ltd.

See all devices from Siemens Shanghai Medical Equipment Ltd. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)