Medical device licence · 4975 · Class 2
GASTROINTESTINAL MANOMETRIC ASSEMBLY
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed June 14, 1999; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 4975
- Licence holder
- Dentsleeve Pty LtdWayville, SA, Australia
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 14, 1999
- Ended
- February 16, 2004
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT ANORECTAL SLEEVE (ASS) AND SIDEHOLE (ASH) ASSEMBLIES
- ADULT LOWER OESOPHAGEAL SPHINCTER (LOSS) ASSEMBLIES
- ADULT PYLORIC SLEEVE (PYS) ASSEMBLIES
- ADULT SIDE HOLE ONLY ANTROPYLORODUODENAL & SMALL INTESTINAL
- ADULT SIDE HOLE ONLY OESOPHAGEAL (OSH) ASSEMBLIES
- ADULT UPPER OESOPHAGEAL SPHINCTER (UOSS) ASSEMBLIES
- CHILD SLEEVE AND SIDEHOLE ONLY ASSEMBLIES (ESO & ANORECTAL)
- NEONATE SLEEVE AND SIDEHOLE ONLY ASSEMBLIES (ESO & PYLONE)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.