ApprovalTrail

Medical device licence · 98912 · Class 2

BIOTEX NON-ABSORBABLE PTFE SUTURE

Yes: licensed in Canada

Licence status Issued (active); first licensed March 31, 2017. It is in Health Canada’s list of active licences.
Licence number
98912
Licence holder
Purgo Biologics Inc.Seongnam-Si, GD, South Korea
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
March 31, 2017
Devices covered
1

Devices on this licence

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

  • BIOTEX PTFE (PFOA FREE) SUTURE

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