ApprovalTrail

Medical device licence · 77266 · Class 2

CUSTO HOLTER RECORDERS

No longer licensed: suspended: invalid quality-system certificate

Licence status Suspended: invalid quality-system certificate; first licensed June 3, 2008; ended July 25, 2013. It is in Health Canada’s archive of licences no longer in force.
Licence number
77266
Licence holder
Custo Med GmbhOttobrunn, Germany
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
June 3, 2008
Ended
July 25, 2013
Devices covered
8

Devices on this licence

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

  • CUSTO COR 12
  • CUSTO COR 3
  • CUSTO COR 6
  • CUSTO FLASH 110
  • CUSTO FLASH 220
  • CUSTO FLASH 500
  • CUSTO FLASH 501
  • CUSTO FLASH 510

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