ApprovalTrail

Medical device licence · 79041 · Class 2

ERGOCONTROL BICYCLE ERGOMETER

No longer licensed: suspended: invalid quality-system certificate

Licence status Suspended: invalid quality-system certificate; first licensed February 10, 2009; ended July 25, 2013. It is in Health Canada’s archive of licences no longer in force.
Licence number
79041
Licence holder
Custo Med GmbhOttobrunn, 09, Germany
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
February 10, 2009
Ended
July 25, 2013
Devices covered
3

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • ERGOCONTROL EC 3000, BICYCLE ERGOMETER
  • ERGOCONTROL EC 3100, BICYCLE ERGOMETER, WITH INTEGRATED ECG MODULE
  • ERGOCONTROL EC3100, BICYCLE ERGOMETER,W/INTEGRATED ECG & BLOOD PRESSURE MOD

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.