Medical device licence · 60544 · Class 2
SPEEDICATH
Yes: licensed in Canada
Licence status Issued (active); first licensed September 23, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 60544
- Licence holder
- Coloplast Corp.North Mankato, Minnesota, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- September 23, 2002
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SPEEDICATH - BOY URETHRAL CATHETER
- SPEEDICATH - FEMALE URETHRAL CATHETER
- SPEEDICATH - NELATON URETHRAL CATHETER
- SPEEDICATH - PEDIATRIC URETHRAL CATHETER
- SPEEDICATH - TIEMANN URETHRAL CATHETER
- SPEEDICATH COMPACT EVE
- SPEEDICATH COMPACT FEMALE
- SPEEDICATH COMPACT MALE
- SPEEDICATH COMPACT SET, FEMALE
- SPEEDICATH COMPACT SET, MALE
- SPEEDICATH FLEX
- SPEEDICATH SOFT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.