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Ire Store Channel

by Ire Rayos X, S.A.

Ref Catalogo IREA3_CATCOM_GEN_ED2024_1Model IRE STORE CHANNEL

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 Number8437023626023ISCL9 Basic UDI-DI 84370236260236UDI-DIDate15 Jan 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
IRE STORE CHANNEL, Catalogo IREA3_CATCOM_GEN_ED2024_1
Primary DI / UDI-DI
84370236260236
Basic UDI-DI
8437023626023ISCL9
Direct Marketing DI
84370236260236
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
Device Class
Class I
Special Device Type
Software
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001652

From the manufacturer

Manufacturer's product page: IRE Store Channel (PACS)

Other devices from Ire Rayos X, S.A.

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