ApprovalTrail

Medical device licence · 85350 · Class 2

HEATER UNIT HU 35

Yes: licensed in Canada

Licence status Issued (active); first licensed March 1, 2011. It is in Health Canada’s list of active licences.
Licence number
85350
Licence holder
Maquet Cardiopulmonary GmbhRastatt, Germany
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
March 1, 2011
Devices covered
4

Devices on this licence

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

  • HEATER UNIT HU35
  • HU 35 COUNTRY KIT
  • HU 35 COUPLING KIT
  • HU 35 WATER TUBING KIT

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