ApprovalTrail

Medical device licence · 80029 · Class 2

EMERGENCY EYEWASH

No longer licensed: suspended: invalid quality-system certificate

Licence status Suspended: invalid quality-system certificate; first licensed June 23, 2009; ended August 28, 2015. It is in Health Canada’s archive of licences no longer in force.
Licence number
80029
Licence holder
Sperian Eye & Face Protection, Inc., A Honeywell CompanyPlatteville, WI, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
June 23, 2009
Ended
August 28, 2015
Devices covered
9

Devices on this licence

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

  • FENDALL FLASH FLOOD REFILL CARTRIDGE
  • FENDALL PURE FLOW 1000 HIGH HUMIDITY STERILE SALINE CARTRIDGE
  • FENDALL PURE FLOW 1000 SALINE CARTRIDGE
  • FENDALL PURE FLOW 1000 STERILE SALINE CARTRIDGE
  • SPERIAN SALINE CONCENTRATE
  • SPERIAN SALINE PERSONAL EYEWASH
  • SPERIAN SALINE SOLUTION
  • SPERIAN WATER ADDITIVE
  • STERILE SALINE CARTRIDGE FOR FENDALL 2000

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