ApprovalTrail

Medical device licence · 79031 · Class 2

CARTO 3 SYSTEM EXTERNAL REFERENCE PATCHES

Yes: licensed in Canada

Licence status Issued (active); first licensed February 9, 2009. It is in Health Canada’s list of active licences.
Licence number
79031
Licence holder
Biosense Webster, Inc.Irvine, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
Single Device
First licensed
February 9, 2009
Devices covered
1

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • CARTO 3 SYSTEM EXTERNAL REFERENCE PATCHES

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.

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.