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ARTIS icono.explore floor

by Siemens Healthcare GmbH

Ref 11832000Model MDR-SHAG_01_IIb_FOR_ACDV_ARTIS explore-genio_floor

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
United StatesGUDID listing GUDID Number04068151011807 UDI-DI Date15 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0405686902313V9 Basic UDI-DI 04068151011807UDI-DIDate28 Apr 2026RegisteredStatusActive

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  • Withdrawn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
Stationary angiographic x-ray system, digital
Device Name
MDR-SHAG_01_IIb_FOR_ACDV_ARTIS explore-genio_floor
Model / Reference
MDR-SHAG_01_IIb_FOR_ACDV_ARTIS explore-genio_floor, 11832000
Primary DI / UDI-DI
04068151011807
Basic UDI-DI
0405686902313V9
510(k) Number
FDA Product Code
JAA, IZI, OWB, JAK
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, 892.1600, 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
DE-MF-000006122

Other devices from Siemens Healthcare GmbH

See all devices from Siemens Healthcare GmbH →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number

Other properties (21)

  • 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
  • Incorporates Medicinal Product: 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