Medical device licence · 96649 · Class 3
THINPREP 5000 PROCESSOR
Yes: licensed in Canada
Licence status Issued (active); first licensed March 14, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96649
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 14, 2016
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NON-GYN FILTER
- PRESERVCYT SOLUTION
- THINPREP 5000 AUTOLOADER
- THINPREP 5000 PROCESSOR
- THINPREP GYN FILTERS
- THINPREP IMAGER SLIDES
- THINPREP MICROSCOPE SLIDE
- THINPREP PAP TEST SLIDES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.