ApprovalTrail

Medical device licence · 82982 · Class 2

CAPILLARYS 2 FLEX PIERCING

Yes: licensed in Canada

Licence status Issued (active); first licensed June 7, 2010. It is in Health Canada’s list of active licences.
Licence number
82982
Licence holder
SebiaEvry Cedex, France
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
June 7, 2010
Devices covered
14

Devices on this licence

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

  • CAPILLARYS 2 FLEX PIERCING - CAPILLARYS CDT (2) KIT
  • CAPILLARYS 2 FLEX PIERCING - CDT KIT (CARBOHYDRATE DEFIC. TRANSFERRIN)
  • CAPILLARYS 2 FLEX PIERCING - HB A1C CALIBRATORS
  • CAPILLARYS 2 FLEX PIERCING - HB A1C KIT
  • CAPILLARYS 2 FLEX PIERCING - HEMOGLOBIN (E) KIT
  • CAPILLARYS 2 FLEX PIERCING - INSTRUMENT
  • CAPILLARYS 2 FLEX PIERCING - IT (IMMUNOTYPING) KIT
  • CAPILLARYS 2 FLEX PIERCING - IT/IF CONTROL
  • CAPILLARYS 2 FLEX PIERCING - PROTEIN (E) 6 KIT
  • CAPILLARYS 2 FLEX PIERCING - TETRAVALENT CDT/IS KIT
  • CAPILLARYS 2 FLEX PIERCING - URINE PREPARATION KIT
  • CDT CAPILLARYS CALIBRATORS (2 LEVELS)
  • HIGH CDT CONTROL
  • MULTI-SYSTEM HB A1C CAPILLARY CONTROLS (2)

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