ApprovalTrail

Medical device licence · 86943 · Class 2

PURECEPTION SPERM SEPARATION MEDIA

Yes: licensed in Canada

Licence status Issued (active); first licensed August 17, 2011. It is in Health Canada’s list of active licences.
Licence number
86943
Licence holder
Coopersurgical, Inc.Trumbull, CT, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
August 17, 2011
Devices covered
4

Devices on this licence

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

  • PURECEPTION 100% ISOTONIC SOLUTION
  • PURECEPTION 40% UPPER PHASE GRADIENT
  • PURECEPTION 80% LOWER PHASE GRADIENT
  • PURECEPTION BI-LAYER KIT

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