ApprovalTrail

Medical device licence · 111045 · Class 2

GENERAL PURPOSE NEEDLE GUIDES

Yes: licensed in Canada

Licence status Issued (active); first licensed April 3, 2024. It is in Health Canada’s list of active licences.
Licence number
111045
Licence holder
Aspen Surgical Products, Inc.Caledonia, MI, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
April 3, 2024
Devices covered
7

Devices on this licence

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

  • BIOPSY / NEEDLE GUIDES
  • LNGC14GX STERILE DISPOSABLE NEEDLE GUIDE CLOSE
  • LNGC1619PX STERILE DISPOSABLE NEEDLE GUIDE CLOSE
  • LNGC2022YX STERILE DISPOSABLE NEEDLE GUIDE
  • LNGO1619PX STERILE DISPOSABLE NEEDLE GUIDE OPEN
  • LNGO2022YX STERILE DISPOSABLE NEEDLE GUIDE OPEN
  • MUL GAUGE NEEDLE GUIDE

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