ApprovalTrail

Medical device licence · 81472 · Class 2

TEST1 2.0

Yes: licensed in Canada

Licence status Issued (active); first licensed December 11, 2009. It is in Health Canada’s list of active licences.
Licence number
81472
Licence holder
Alifax S.R.L.Nimis, UD, Italy
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
December 11, 2009
Devices covered
7

Devices on this licence

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

  • LATEX EQE (2 TESTS)
  • TEST1 2.0
  • TEST1 SYSTEM - LATEX CALIBRATORS
  • TEST1 SYSTEM - LATEX CALIBRATORS IN SARSTEDT TUBES
  • TEST1 SYSTEM - LATEX CONTROLS
  • TEST1 SYSTEM - LATEX CONTROLS IN SARSTEDT TUBES
  • TEST1 SYSTEM - SMART CARD

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