ApprovalTrail

Medical device licence · 65830 · Class 2

ALLURA 3D-CA

Yes: licensed in Canada

Licence status Issued (active); first licensed September 15, 2004. It is in Health Canada’s list of active licences.
Licence number
65830
Licence holder
Philips Medical Systems Nederland B.V.Orange Village, OH, United States
Risk class
Class II (low to moderate risk)
Licence type
Single Device
First licensed
September 15, 2004
Devices covered
2

Devices on this licence

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

  • 3D-CA
  • ALLURA 3D-CA

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 “allura”. 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.