Medical device licence · 60660 · Class 2
TRANSANAL ENDOSCOPIC MICROSURGERY SYSTEM (TEM)
Yes: licensed in Canada
Licence status Issued (active); first licensed October 4, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 60660
- Licence holder
- Richard Wolf GmbhKnittlingen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 4, 2002
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TEM ADAPTER WITH VIEWING WINDOW AND ILLUMINATION INSERT
- TEM COMBINATIONS SYSTEM
- TEM CONNECTING TUBE
- TEM FOOTSWITCH
- TEM GAS HUMIDIFIER
- TEM HYGIENE FILTER
- TEM INSUFFLATION TUBING
- TEM LAPARO CO2 PNEU
- TEM MAIN ELEMENT
- TEM PUMP
- TEM RECTOSCOPE TUBE, INCLUDING OBTURATOR
- TEM SUTURE STAPLES
- TEM WORKING INSERT
- TITANIUM CLIP, STERILE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.