Medical device licence · 32412 · Class 3
COLOCARE (HOME USE)
Yes: licensed in Canada
Licence status Issued (active); first licensed October 1, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 32412
- Licence holder
- Helena Laboratories, CorpBeaumont, TX, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Test Kit
- First licensed
- October 1, 2001
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COLOCARE HOSPITAL PACK
- COLOCARE OFFICE PACK
- COLOCARE SCREENING PACKS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.