Medical device licence · 3803 · Class 2
ES SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed June 2, 1999; ended October 31, 2001. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 3803
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 2, 1999
- Ended
- October 31, 2001
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ES SYSTEM - ANTI-HAV
- ES SYSTEM - ANTI-HAV IGM
- ES SYSTEM - CORTISOL
- ES SYSTEM - DIGOXIN
- ES SYSTEM - ES300 ANALYZER - CLASS 2
- ES SYSTEM - FERRITIN
- ES SYSTEM - FOLLICALE STIMULATING HORMONE
- ES SYSTEM - FREE T3
- ES SYSTEM - FREE T4
- ES SYSTEM - IGE
- ES SYSTEM - INSULIN
- ES SYSTEM - LUTENIZING HORMONE (LH)
- ES SYSTEM - OESTRADIOL (ESTRADIOL)
- ES SYSTEM - OESTRADIOL IVF (ESTRADIOL)
- ES SYSTEM - PROGESTERONE
- ES SYSTEM - PROLACTIN
- ES SYSTEM - T3
- ES SYSTEM - T4
- ES SYSTEM - TEST TSH HYPER
- ES SYSTEM - THYROXIN BINDING GLOBULIN (TGB)
- ES SYSTEM - TSH
- ES SYSTEM THYROXIN BINDING CAPACITY (TBK)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.