Medical device licence · 7668 · Class 3
STRATUS CS ACUTE CARE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 19, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 7668
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 19, 1999
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- STRATUS CS 200
- STRATUS CS ACUTE CARE SYS - CARDIOPHASE HIGH SENSITIVITY CRP (CCRP) ASSAY
- STRATUS CS ACUTE CARE SYSTEM - CARDIAC TROPONIN-I TESTPAK
- STRATUS CS ACUTE CARE SYSTEM - CARDIAC CKMB TESTPAK
- STRATUS CS ACUTE CARE SYSTEM - CARDIAC MYOGLOBIN TESTPAK
- STRATUS CS ACUTE CARE SYSTEM - CARDIAC TROPONIN - I TESTPAK
- STRATUS CS ACUTE CARE SYSTEM - CTNI CALPAK
- STRATUS CS ACUTE CARE SYSTEM - D-DIMER (DDMR) ASSAY
- STRATUS CS ACUTE CARE SYSTEM - FLOUROMETRIC ANALYZER
- STRATUS CS ACUTE CARE SYSTEM - NT-PROBNP (PBNP) ASSAY
- STRATUS CS ACUTE CARE SYSTEM - PBNP TESTPAK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.