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Hiris Tsi

by A.T.S. Applicazione Tecnologie Speciali s.r.l. EUDAMED

Active European Union

Ref SI 11 001Model HIRIS TSI

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805518667HIRISTSIEW Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

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.

Specification

EUDAMED

Model / Reference
HIRIS TSI, SI 11 001
Primary DI / UDI-DI
08055186671416
Basic UDI-DI
805518667HIRISTSIEW
EMDN Code
Z11031192 Systems for direct digital radiology (dr) - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
France

Manufacturer details

EUDAMED SRN
IT-MF-000010734

Other devices from A.T.S. Applicazione Tecnologie Speciali s.r.l.

See all devices from A.T.S. Applicazione Tecnologie Speciali s.r.l. →

Properties

Other properties (13)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No