Skip to content

Software Para Sistemas De Información Y Gestión De Imágenes Radiológicas - Hiruko

by Imaging Experts and Healthcare Services S.A.S

Ref HIRUKO

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number770999730956019B Basic UDI-DI 77094295747988UDI-DIDate28 Feb 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Software Para Sistemas De Información Y Gestión De Imágenes Radiológicas
Model / Reference
HIRUKO
Primary DI / UDI-DI
77094295747988
Basic UDI-DI
770999730956019B
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Special Device Type
Software
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CO-MF-000019356
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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