Medical device licence · 21950 · Class 2
COLOSCREEN/COLOSCREEN ES
Yes: licensed in Canada
Licence status Issued (active); first licensed July 10, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 21950
- Licence holder
- Helena Laboratories, CorpBeaumont, TX, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- July 10, 2000
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COLOSCREEN III LAB PACK
- COLOSCREEN III OFFICE PACK
- COLOSCREEN LAB PACK
- COLOSCREEN TAPE
- COLOSCREEN-ES LAB PACK
- COLOSCREEN-ES OFFICE PACK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.