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Article 22 Comb. ARTIS/Artis one

by Siemens Shenzhen Magnetic Resonance Ltd. China EUDAMED

Ref 11328308Model MDR_SPPP_01_IIb_SHZ_Combination_Artis one EMDN Z11030102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0405686902223V7 Basic UDI-DIDate2 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
MDR_SPPP_01_IIb_SHZ_Combination_Artis one
Model / Reference
MDR_SPPP_01_IIb_SHZ_Combination_Artis one, 11328308
Primary DI / UDI-DI
04056869977959
Basic UDI-DI
0405686902223V7
EMDN Code
Z11030102 Stationary angiography systems for angiographic and cardiologic studies
Device Class
Class IIb
Medical Purpose
Diagnostic image guidance in non-vascular, vascular, cardio-vascular, neuro-vascular, minimal-surgical, and surgical procedures

Manufacturer details

EUDAMED SRN
CN-PR-000020467

Other devices from Siemens Shenzhen Magnetic Resonance Ltd.

See all devices from Siemens Shenzhen Magnetic Resonance Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED a152fc26-68a0-481b-b73f-9f21afdbda3c 61 fields · synced 22 Oct 2026