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Eracle

by Digitec S.r.l. Italy EUDAMED

Ref DRF_01_002

EMDN Z11031192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805347039TIRESYAWB Basic UDI-DIDate20 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Tiresya
Model / Reference
DRF_01_002
Primary DI / UDI-DI
08053470391019
Basic UDI-DI
805347039TIRESYAWB
Direct Marketing DI
08053470391019
EMDN Code
Z11031192 Systems for direct digital radiology (dr) - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000007792

Other devices from Digitec S.r.l.

See all devices from Digitec S.r.l. →

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 (1)

  • EUDAMED ab21b353-a266-4d76-b8ce-ca63c41ef698 61 fields · synced 23 Oct 2026