ApprovalTrail

Medical device licence · 92062 · Class 3

SMARTABLATE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed October 8, 2013. It is in Health Canada’s list of active licences.
Licence number
92062
Licence holder
Stockert GmbhFreiburg, Germany
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
October 8, 2013
Devices covered
18

Devices on this licence

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

  • SMARTABLATE ACCESSORY - CONNECTION CABLE FOR 3M INDIFFERENT ELECTRODE
  • SMARTABLATE ACCESSORY - CONNECTION CABLE FOR ERBE INDIFFERENT ELECTRODE
  • SMARTABLATE ACCESSORY - CONNECTION CABLE FOR PHILIPS ESOPHAGEAL PROBE
  • SMARTABLATE ACCESSORY - CONNECTION CABLE FOR SMITHS ESOPHAGEAL PROBE (RECTANGULAR)
  • SMARTABLATE ACCESSORY - CONNECTION CABLE IRRIGATION PUMP
  • SMARTABLATE ACCESSORY - CONNECTION CABLE REMOTE CONTROL
  • SMARTABLATE ACCESSORY - ECG CONNECTION CABLE
  • SMARTABLATE ACCESSORY - ERBE INDIFFERENT ELECTRODE
  • SMARTABLATE ACCESSORY - GROUNDING CABLE
  • SMARTABLATE ACCESSORY - POWER (MAINS) CABLE
  • SMARTABLATE ACCESSORY - SERIAL DATA COMMUNICATION CABLE RECORDING-/CARTO SYSTEMS
  • SMARTABLATE SYSTEM (SUPER KIT)
  • SMARTABLATE SYSTEM FOOT PEDAL
  • SMARTABLATE SYSTEM FOOT PEDAL EXTENSION CABLE
  • SMARTABLATE SYSTEM REMOTE CONTROL
  • SMARTABLATE SYSTEM REMOTE CONTROL KIT
  • SMARTABLATE SYSTEM RF GENERATOR
  • SMARTABLATE SYSTEM RF GENERATOR KIT

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