Medical device licence · 80382 · Class 2
DISPOSABLE SPHINCTEROTOMES
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 6, 2009; ended November 27, 2017. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 80382
- Licence holder
- Endo-Flex GmbhVoerde, 05, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- August 6, 2009
- Ended
- November 27, 2017
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NEEDLE-KNIFE SPHINCTEROTOMES (DISPOSABLE) 1.8 MM, BLUNT TYPE, SINGLE LUMEN
- NEEDLE-KNIFE SPHINCTEROTOMES (DISPOSABLE) 1.8 MM, POINTED TYPE SINGLE LUMEN
- SPHINCTEROTOMES (DISPOSABLE) 1.8 MM DIAMETER, SINGLE LUMEN, PRECUT TYPE
- SPHINCTEROTOMES (DISPOSABLE) 1.8 MM DIAMETER, SINGLE LUMEN, TAPERED TIP
- SPHINCTEROTOMES (DISPOSABLE) 1.8 MM,SINGLE LUMEN, PRECUT TYPE W/TAPERED TIP
- SPHINCTEROTOMES (DISPOSABLE) 2.2 MM DIAMETER, PRECUT TYPE, DOUBLE LUMEN
- SPHINCTEROTOMES (DISPOSABLE) 2.2 MM DIAMETER, PRECUT TYPE, TRIPLE LUMEN
- SPHINCTEROTOMES (DISPOSABLE) 2.2 MM DIAMETER, STANDARD TIP, DOUBLE LUMEN
- SPHINCTEROTOMES (DISPOSABLE) 2.2 MM DIAMETER, TAPERED TIP, DOUBLE LUMEN
- SPHINCTEROTOMES (DISPOSABLE) 2.2 MM DIAMETER, TAPERED TIP, TRIPLE LUMEN
- SPHINCTEROTOMES (DISPOSABLE) 2.2 MM, "SMART CUT", TAPERED TIP, DOUBLE LUMEN
- SPHINCTEROTOMES (DISPOSABLE) 2.2 MM, "SMART CUT", TAPERED TIP, TRIPLE LUMEN
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.