Medical device licence · 67028 · Class 2
PILLCAM ENDOSCOPY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 7, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 67028
- Licence holder
- Given Imaging, Inc.Mansfield, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 7, 2005
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COLON 2 SENSOR BELT
- DATARECORDER DR2C - PAEDIATRIC SET
- DATARECORDER DR2C SET
- PILLCAM DATA RECORDER
- PILLCAM RECORDER ACCESSORIES
- PILLCAM RECORDER CRADLE
- PILLCAM SENSOR ARRAYS
- PILLCAM SENSOR BELT
- PILLCAM SENSOR SLEEVES
- PILLCAM SMALL SENSOR ARRAY
- PILLCAM SOFTWARE
- PILLCAM WORKSTATION
- RAPID REAL TIME SOFTWARE UPGRADE KIT
- RAPID REAL-TIME RT SYSTEM - MAIN UNIT
- SB SENSOR BELT- DR2
- SB SENSOR BELTS- DR3
- SENSOR ARRAY, 3 LEAD (DR2-ESO)
- SENSOR ARRAY, 3 LEAD (DR3-ESO)
- SENSOR ARRAY, 8 LEAD (DR2-SB AND COLON)
- SMALL ACCESSORY KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.