ApprovalTrail

Medical device licence · 97445 · Class 2

SPERM CLASS ANALYZER-SCA EVOLUTION

No longer licensed: cancelled: renewal not answered

Licence status Cancelled: renewal not answered; first licensed August 5, 2016; ended October 31, 2018. It is in Health Canada’s archive of licences no longer in force.
Licence number
97445
Licence holder
Microptic S.L.Barcelona, Spain
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
August 5, 2016
Ended
October 31, 2018
Devices covered
14

Devices on this licence

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

  • CASA SPERM CLASS ANALYZER - SCA EVOLUTION
  • SCA DATASHARE
  • SCA DNA FRAGMENTATION (HUMAN EDITION)
  • SCA DNA FRAGMENTATION (LITE EDITION)
  • SCA MANUAL COUNTER
  • SCA MORPHOLOGY (HUMAN EDITION)
  • SCA MORPHOLOGY (LITE EDITION)
  • SCA MOTILITY AND CONCENTRATION (HUMAN EDITION)
  • SCA MOTILITY AND CONCENTRATION (LITE EDITION)
  • SCA PACK HUMAN EDITION
  • SCA PACK LITE EDITION
  • SCA SAMPLE MANAGEMENT
  • SCA VITALITY (HUMAN EDITION)
  • SCA VITALITY (LITE EDITION)

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