Medical device licence · 82611 · Class 3
DIASPECT HEMOGLOBIN
Yes: licensed in Canada
Licence status Issued (active); first licensed April 19, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82611
- Licence holder
- Ekf-Diagnostic GmbhBarleben, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 19, 2010
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIASPECT HEMOGLOBIN SYSTEM - CONTROL PACK HB
- DIASPECT HEMOGLOBIN SYSTEM - CUVETTE
- DIASPECT HEMOGLOBIN SYSTEM - INSTRUMENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.