HeartView

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Device Name

HeartView

Model / Reference

12i

Primary DI / UDI-DI

D-HeartView-12iZM

Basic UDI-DI

B-HeartView-12iZM

EMDN Code

Z12050403 ECG holter recorders

Device Class

Class IIa

EU market of registration

Ireland

EUDAMED SRN

IL-MF-000038449

Authorised representative

AF Pharma Service Europe SL ES-AR-000018076

• Heart 2006

  Class II

  FDA 510(k) K032736 Active Cleared 3 Oct 2003

• Heartline Receiving Station

  Class II

  FDA 510(k) K022073 Active Cleared 24 Jul 2002

• Heart 2005

  Class II

  FDA 510(k) K000775 Active Cleared 17 May 2000

• Bp-Tel Trans-Telephonic Blood Pressure Measurement System

  Class II

  FDA 510(k) K983717 Active Cleared 16 Sep 1999

• Mpm-Net

  Class II

  FDA 510(k) K030825 Active Cleared 28 Mar 2003

• Heartone Event Recorder and Transmitter

  Class II

  FDA 510(k) K023418 Active Cleared 6 Nov 2002

See all devices from Aerotel Medical Systems (1998) Ltd. →