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Artis one 10848600

by Siemens Shenzhen Magnetic Resonance Ltd.

Ref 10848600Model MDR_01_IIb_SZN_ACDV_Artis one

Artis one 10848600 is a stationary angiographic x-ray system (EU MDR Class IIb; FDA Class II) made by Siemens Shenzhen Magnetic Resonance Ltd., registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 0405686900120UE) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04056869009964), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686900120UE Basic UDI-DI 04056869009964UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04056869009964 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0405686900120UE registered 1 Jul 2026 Active
  • FDA GUDID UDI-DI 04056869009964 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04056869009964
  2. Registered EUDAMED 0405686900120UE

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  • Withdrawn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
Artis one
Generic name
Stationary angiographic x-ray system, digital
Device name
MDR_01_IIb_SZN_ACDV_Artis one
Model / reference
10848600, MDR_01_IIb_SZN_ACDV_Artis one
Primary DI / UDI-DI
04056869009964
Basic UDI-DI
0405686900120UE
FDA product code
OWB, JAA
EMDN code
Z11030102 Stationary angiography systems for angiographic and cardiologic studies
GMDN term
Stationary angiographic 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
France
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: Stationary angiographic x-ray system, digital

Similar devices in this category

Other devices filed under STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES.

Other devices from Siemens Shenzhen Magnetic Resonance Ltd.

See all devices from Siemens Shenzhen Magnetic Resonance Ltd. →

Properties

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