Medical device licence · 69138 · Class 2
STA-R EVOLUTION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 22, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 69138
- Licence holder
- Diagnostica Stago SasAsnieres Sur Seine, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 22, 2005
- Devices covered
- 49
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- POOL NORM
- STA - COAG CONTROL (N+ABN) PLUS
- STA - CONTROL LA 1+2, STA - STACLOT DRVV SCREEN 5, STA - STACLOT DRVV CONFIRM, STA - STACLOT DRVV SCREEN 2
- STA - DABIGATRAN CALIBRATOR
- STA - DABIGATRAN CONTROL
- STA - DEFICIENT IX
- STA - DEFICIENT V
- STA - DEFICIENT VII
- STA - DEFICIENT VIII
- STA - DEFICIENT X
- STA - DEFICIENT XI
- STA - DEFICIENT XII
- STA - ECA II
- STA - FONDAPARINUX CALIBRATOR
- STA - FONDAPARINUX CONTROL
- STA - HBPM/LMWH CONTROL
- STA - HEPARIN CONTROL
- STA - HERPANORM H
- STA - IMMUNODEF II
- STA - IMMUNODEF IX
- STA - IMMUNODEF VIII
- STA - IMMUNODEF XI
- STA - IMMUNODEF XII
- STA - LIATEST D-DI, STA - LIATEST CONTROL N +P
- STA - LIATEST FM, STA- FM CALIBRATOR, STA - FM CONTROL
- STA - LIATEST FREE PROTEIN S2, STA - LIATEST FREE PROTEIN S6
- STA - LIATEST VWF:AG, STA - VWF:AG CALIBRATOR
- STA - LIQUID ANTI-XA 4
- STA - LIQUID ANTI-XA 8
- STA - MULTI HEP CALIBRATOR
- STA - QUALITY HBPM/LMWH
- STA - QUALITY HNF/UFH
- STA - REPTILASE
- STA - STACHROM AT III 3, STA- STACHROM AT III 6
- STA - STACHROM PLASMINOGEN
- STA - STACHROM PROTEIN C
- STA - STACLOT HEPARIN
- STA - STACLOT PROTEIN C 3
- STA - STACLOT PROTEIN C1
- STA - STACLOT PROTEIN S
- STA - THROMBIN 2, STA - THROMBIN 10
- STA - VWF:RCO
- STA R MAX 2
- STA STACLOT APC-R
- STA-DEFICIENT II
- STA-HEPANORM HBPM/LMWH
- STA-R EVOLUTION SYSTEM - LOGICIEL - VERSION 3.02.01
- STA-R EVOLUTION SYSTEM - SOFTWARE VERSION 2.40-19
- STA-R EVOLUTION SYSTEM - SOFTWARE VERSION 3.01.01
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.