Medical device licence · 21452 · Class 3
ES SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed June 13, 2000; ended October 31, 2000. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 21452
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 13, 2000
- Ended
- October 31, 2000
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ES SYSTEM - AFP
- ES SYSTEM - CA 125 II
- ES SYSTEM - CA 15-3
- ES SYSTEM - CA 19-9
- ES SYSTEM - CA 72-4
- ES SYSTEM - CEA
- ES SYSTEM - CONTROL FOR TUMOR MARKER
- ES SYSTEM - ES 300 ANALYZER - CLASS 3
- ES SYSTEM - PSA
- ES SYSTEM - PSA
- ES SYSTEM - TROPONIN T
- ES SYSTEM- HCG
- PRECINORM IM, NORMAL AND ABNORMAL CONTROL FOR ES SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.