ApprovalTrail

Medical device licence · 374 · Class 3

PCS 2 PLASMA COLLECTION SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed November 19, 1998. It is in Health Canada’s list of active licences.
Licence number
374
Licence holder
Haemonetics CorporationBoston, Massachusetts, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
November 19, 1998
Devices covered
7

Devices on this licence

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

  • PCS2
  • PCS2 PLASMA COLLECTION SYSTEM - DISPOSAL COLLECTION KITS
  • PCS2 PLASMA COLLECTION SYSTEM - HS PLS BOWL
  • PCS2 PLASMA COLLECTION SYSTEM - PLASMA POOLING BOTTLE
  • PCS2 PLASMA COLLECTION SYSTEM - PLASMA POOLING BOTTLE W/SALINE ADAPTOR
  • PCS2 PLASMA COLLECTION SYSTEM - PLS CLOSED SETS - DISPOSABLE COLLECTION KITS
  • PCS2 PLASMA COLLECTION SYSTEM - PLS HARNESS SETS, W/DRIP

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