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Inside C-Arm

by Digitec S.r.l. Italy EUDAMED

Ref ARM_01_006

EMDN Z11031192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8053470393DCAMZ6 Basic UDI-DIDate3 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
3D-Cam Pilot
Tiresya
Model / Reference
ARM_01_006
Primary DI / UDI-DI
08053470390173
Basic UDI-DI
8053470393DCAMZ6, 805347039TIRESYAWB
Direct Marketing DI
08053470390173
EMDN Code
Z11031192 Systems for direct digital radiology (dr) - medical device software
Device Class
Class I
Class IIb
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000007792

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: 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

Sources (2)

  • EUDAMED 23bfec25-e2cc-4442-8cc2-16a370215edc 61 fields · synced 22 Oct 2026
  • EUDAMED dde327f5-8b03-4162-9b9a-2b2108fb66eb 61 fields · synced 1 Aug 2026