Skip to content

Horizon Cardiology

by Change Healthcare Canada Company

Ref 12.2

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-HC12.2_GH Basic UDI-DI D-HC12.2_GHUDI-DIDate12 Aug 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
12.2
Primary DI / UDI-DI
D-HC12.2_GH
Basic UDI-DI
B-HC12.2_GH
EMDN Code
Z110603 Picture archiving and communication systems
Device Class
Class IIa
Special Device Type
-1192
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CA-MF-000032718
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Change Healthcare Canada Company

See all devices from Change Healthcare Canada Company →

Properties

  • Measuring Function

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No