ApprovalTrail

Medical device licence · 116077 · Class 2

PY TEST BREATH COLLECTION KIT

Yes: licensed in Canada

Licence status Issued (active); first licensed September 1, 2026. It is in Health Canada’s list of active licences.
Licence number
116077
Risk class
Class II (low to moderate risk)
Licence type
Test Kit
First licensed
September 1, 2026
Devices covered
13

Devices on this licence

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

  • PYTEST BALLONS AND STRAWS
  • PYTEST BLUNT NEEDLE SET
  • PYTEST DISPENSER
  • PYTEST MICROCOUNT LITE
  • PYTEST AIR PUMP
  • PYTEST BREATH COLLECTION FLUID
  • PYTEST CAPSULES
  • PYTEST GLASS VIALS
  • PYTEST KIT WITH SHIPPING BOX
  • PYTEST KIT WITHOUT SHIPPING BOX
  • PYTEST MEDICINE CUPS
  • PYTEST SCINTILLATION FLUID
  • PYTEST STANDARD SET

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