Medical device licence · 93718 · Class 2
BENCHMARK INTRACRANIAL ACCESS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 12, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93718
- Licence holder
- Penumbra Inc.Alameda, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- August 12, 2014
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BENCHMARK
- BENCHMARK BMX 81 ACCESS SYSTEM
- BENCHMARK BMX96
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 “benchmark”. A notice may cover another product or only some lots: read it to see what it covers.
- Benchmark Ultra Stainer ModuleFebruary 8, 2022 · Pathology · Manufacturing defect · Type II
- Benchmark ULTRA Automated Immunostaining System (2020-09-10)September 25, 2020 · Medical devices · Medical devices · Type II
- Benchmark Ultra Automated Immunostaining System & Benchmark XT (2020-04-08)May 8, 2020 · Medical devices · Medical devices · Type III
- BenchMark ULTRA instruments (2019-01-23)March 1, 2019 · Medical devices · Medical devices · Type III
- BENCHMARK ULTRA AUTOMATED IMMUNOSTAINING SYSTEM (2015-11-26)January 7, 2016 · Medical devices · Health products · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.