Medical device licence · 71353 · Class 3
BIOTESTCELL
Yes: licensed in Canada
Licence status Issued (active); first licensed May 12, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71353
- Licence holder
- Bio-Rad Medical Diagnostics GmbhDreieich, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- May 12, 2006
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOTESTCELL -I11
- BIOTESTCELL -I8
- BIOTESTCELL -P1,P2
- BIOTESTCELL -P3
- BIOTESTCELL-DIA
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “biotestcell”. A notice may cover another product or only some lots: read it to see what it covers.
- BIOTESTCELL -I11 (2015-06-05)July 21, 2015 · Medical devices · Health products · Type III
- Biotestcell -I 8 and I 11 (2014-06-17)July 7, 2014 · Medical devices · Medical devices · Type I
- Biotestcell P3October 1, 2012 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.