ApprovalTrail

Medical device licence · 78881 · Class 4

EXCOR SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed January 23, 2009. It is in Health Canada’s list of active licences.
Licence number
78881
Licence holder
Berlin Heart GmbhBerlin, Germany
Risk class
Class IV (highest risk)
Licence type
System
First licensed
January 23, 2009
Devices covered
33

Devices on this licence

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

  • APEX CANNULA FOR CHILDREN, STAGED
  • APEX CANNULA FOR SMALL CHILDREN
  • APEX CANNULA ONE-PART
  • CANNULA EXTENSION SET
  • CONNECTING SET FOR CANNULAS
  • EXCC-006 EXCOR CANNULA CLIP
  • EXCC-009 EXCOR CANNULA CLIP
  • EXCC-012 EXCOR CANNULA CLIP
  • EXCOR ACTIVE ADAPTER FOR EXTERNAL ALARM (NURSE CALL)
  • EXCOR ACTIVE BATTERY
  • EXCOR ACTIVE DOCKING STATION
  • EXCOR ACTIVE DRIVING UNIT
  • EXCOR ACTIVE FLOW SENSOR SET 1: FS06-06-P
  • EXCOR ACTIVE FLOW SENSOR SET 2: FS09-09-P
  • EXCOR ACTIVE FLOW SENSOR SET 3: FS09-12-P
  • EXCOR ACTIVE FLOW SENSOR SET 5: FS12-12-P
  • EXCOR ACTIVE PANEL PC
  • EXCOR ACTIVE POWER CABLE
  • EXCOR ACTIVE POWER SUPPLY UNIT
  • EXCOR ACTIVE POWER SUPPLY UNIT PANEL PC
  • EXCOR ACTIVE USB CABLE
  • EXCOR ACTIVE USB STICK
  • EXCOR SYSTEM - ACCESSORY SET FOR BLOOD PUMP WITH PU VALVES
  • EXCOR SYSTEM - APEX CANNULAS
  • EXCOR SYSTEM - ARTERIAL CANNULAS
  • EXCOR SYSTEM - ATRIAL CANNULAS
  • EXCOR SYSTEM - BLOOD PUMP PU VALVES
  • EXCOR SYSTEM - BLOOD PUMPS
  • EXCOR SYSTEM - CONNECTING SET FOR CANNULAS
  • EXCOR SYSTEM - DRIVING TUBE
  • EXCOR SYSTEM - DRIVING UNIT
  • EXTENSION SET FOR CANNULAS
  • GRAFT-ADAPTER CANNULA

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “excor”. A notice may cover another product or only some lots: read it to see what it covers.

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