Medical device licence · 64566 · Class 4
CLINIMACS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 21, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 64566
- Licence holder
- Miltenyi Biotec B.V. & Co. KgBergisch Gladbach, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- May 21, 2004
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CLINIMACS ANTI-BIOTIN
- CLINIMACS CD19 REAGENT
- CLINIMACS CD4 REAGENT
- CLINIMACS CD8 REAGENT
- CLINIMACS DEPLETION TUBING SET
- CLINIMACS SYSTEM - CD34 REAGENT
- CLINIMACS SYSTEM - INSTRUMENT
- CLINIMACS SYSTEM - PBS/EDTA BUFFER
- CLINIMACS SYSTEM - TUBING SET
- CLINIMACS TCR ALPHA/BETA-BIOTIN
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.