Medical device licence · 61675 · Class 4
ERA 3000 PACING SYSTEM ANALYZER
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 27, 2003; ended October 31, 2013. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 61675
- Licence holder
- Biotronik Se & Co. KgBerlin, 11, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- January 27, 2003
- Ended
- October 31, 2013
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ERA 3000 CHARGER/BATTERY
- ERA 3000 PACEMAKER ADAPTORS
- ERA 3000 PACEMAKER TEST CABLE
- ERA 3000 PACING SYSTEM ANALYZER
- ERA 3000 PATIENT CABLES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.