Medical device licence · 81053 · Class 3
CARTO 3 EP NAVIGATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 2, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81053
- Licence holder
- Biosense Webster (Israel) Ltd.Yokneam, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 2, 2009
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CABLE
- CARTO 3 SYSTEM - CARTOUNIVU MODULE KIT
- CARTO 3 SYSTEM - CATHETER INTERFACE CABLES
- CARTO 3 SYSTEM - ECG KIT
- CARTO 3 SYSTEM - MAIN UNIT AND ACCESSORIES
- CARTO 3 SYSTEM - RMT MODULE
- CARTO 3 SYSTEM - SPU KIT
- CARTO 3 SYSTEM - UPGRADE KIT
- CARTO 3 SYSTEM - VISITAG MODULE KIT
- CARTO 3 SYSTEM CARTO PRIME (OBL)
- CARTO 3 SYSTEM CARTO PRIME WS FRU
- CARTO 3 SYSTEM PIU
- CARTO 3 SYSTEM SOFTWARE VERSION V7.1.80.13 UPGRADE KIT FOR CARTO 3 V7 (OBL)
- CARTO 3 SYSTEM V7.5 UPGRADE KIT
- CARTO 3 SYSTEM V7.5 UPGRADE KIT WITH WIN10 UPGRADE KIT
- CARTO 3 SYSTEM V8 UPGRADE KIT
- CARTO 3 SYSTEM VISITAG SURPOINT INSTALLATION KIT V7
- CONNECTION UNIT
- LOCATION PAD
- PEDAL
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “carto”. A notice may cover another product or only some lots: read it to see what it covers.
- CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath (2021-02-25)March 18, 2021 · Medical devices · Medical devices · Type II
- CARTO 3 EP SYSTEM - CARTOSOUND MODULE (2015-09-25)October 22, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.