Medical device licence · 70623 · Class 3
SUPERDIMENSION NAVIGATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 1, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 70623
- Licence holder
- Covidien LlcChicopee, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 1, 2006
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EDGE BRONCHOSCOPE ADAPTER
- EDGE FIRM TIP ENDOBRONCHIAL PROCEDURE KIT CATHETER
- EDGE FIRM TIP EXTENDED WORKING CHANNEL CATHETER
- SUPERDIMENSION INREACH SYS. - PROCEDURE KIT W/OLYMPUS BRONCHOSCOPE ADAPTER
- SUPERDIMENSION INREACH SYS. - PROCEDURE KIT W/PENTAX BRONCHOSCOPE ADAPTER
- SUPERDIMENSION NAVIGATION SYSTEM
- SUPERDIMENSION NAVIGATION SYSTEM - BRONCHOSCOPE ADAPTER
- SUPERDIMENSION NAVIGATION SYSTEM - BRONCHOSCOPE CLIP
- SUPERDIMENSION NAVIGATION SYSTEM - EDGE LG
- SUPERDIMENSION NAVIGATION SYSTEM - EXTENDED WORKING CHANNEL
- SUPERDIMENSION NAVIGATION SYSTEM - LOCATABLE GUIDE
- SUPERDIMENSION NAVIGATION SYSTEM - LOCATION GUIDE CABLE
- SUPERDIMENSION NAVIGATION SYSTEM - PATIENT SENSOR PATCH
- SUPERDIMENSION NAVIGATION SYSTEM - PATIENT SENSOR TRIPLET
- SUPERDIMENSION NAVIGATION SYSTEM - PROCEDURE KIT W/FUJINON BRONCHOSCOPE ADAPTER
- SUPERDIMENSION NAVIGATION SYSTEM - VERSION 7.1 UPGRADE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.