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Cios Alpha 11105200

by Siemens Healthcare GmbH

Ref 11105200Model MDR_01_IIb_FOR_ACDV_Cios Flow/Alpha/Spin (VA30)

Cios Alpha 11105200 is a portable general-purpose fluoroscopic x-ray system (EU MDR Class IIb; FDA Class II) made by Siemens Healthcare GmbH, registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI 0405686900147V2) and listed in FDA GUDID since 10 Jan 2019 (UDI-DI 04056869153490), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686900147V2 Basic UDI-DI 04056869153490UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04056869153490 UDI-DI Date10 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0405686900147V2 registered 22 Jun 2026 Active
  • FDA GUDID UDI-DI 04056869153490 listed 10 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04056869153490
  2. Registered EUDAMED 0405686900147V2

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  • Withdrawn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 Alpha
Generic name
Portable general-purpose fluoroscopic x-ray system, digital
Device name
MDR_01_IIb_FOR_ACDV_Cios Flow/Alpha/Spin (VA30)
Model / reference
11105200, MDR_01_IIb_FOR_ACDV_Cios Flow/Alpha/Spin (VA30)
Primary DI / UDI-DI
04056869153490
Basic UDI-DI
0405686900147V2
FDA product code
OWB, OXO, JAA
EMDN code
Z11039017 Mobile radioscopic units
GMDN term
Portable general-purpose fluoroscopic x-ray system, digital
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, digital

Similar devices in this category

Other devices filed under MOBILE RADIOSCOPIC UNITS.

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Properties

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