ApprovalTrail

Medical device licence · 62259 · Class 4

BLOOD SCREENING NAT SOFTWARE

No longer licensed: cancelled

Licence status Cancelled; first licensed April 16, 2003; ended May 4, 2026. It is in Health Canada’s archive of licences no longer in force.
Licence number
62259
Licence holder
Roche Molecular Systems, IncBranchburg, NJ, United States
Risk class
Class IV (highest risk)
Licence type
Device Family
First licensed
April 16, 2003
Ended
May 4, 2026
Devices covered
16

Devices on this licence

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

  • BLOOD SCREENING DOMS
  • BLOOD SCREENING DOMS ROUTER
  • COBAS S 201 SYSTEM - CONFIGURATION D SERIES ORACLE PATCH
  • COBAS S 201 SYSTEM - CONFIGURATION D SERIES PATCH
  • COBAS S 201 SYSTEM - CONFIGURATION D SERIES SP2 PDM PATCH
  • COBAS S 201 SYSTEM CONFIGURATION E MR1 PDM SOFTWARE
  • COBAS S 201 SYSTEM CONFIGURATION E PDM SOFTWARE
  • COBAS S201 SYSTEM POOLING AND DATA MANAGEMENT (PDM DMR1) V3.0.32
  • COBAS S201 SYSTEM POOLING AND DATA MANAGEMENT (PDM DMR2) V3.0.35
  • COBAS S201 SYSTEM POOLING AND DATA MANAGEMENT (PDM) V.1.1.8
  • COBAS S201 SYSTEM POOLING AND DATA MANAGEMENT (PDM) V.2.0.10
  • COBAS S201 SYSTEM POOLING AND DATA MANAGEMENT (PDM) V.2.0.14
  • COBAS S201 SYSTEM POOLING AND DATA MANAGEMENT (PDM) V.3.0.23
  • COBAS S201 SYSTEM POOLING AND DATA MANAGEMENT (PDM) V.3.0.27
  • COBAS S201 SYSTEM POOLING AND DATA MANAGEMENT (PDM) V3.0.32
  • COBAS S201 SYSTEM POOLING AND DATA MANAGEMENT (PDM) V3.0.35

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