Medical device licence · 63408 · Class 3
CLINITEK STATUS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 15, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 63408
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 15, 2003
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CLINITEK STATUS SYSTEM - URINE CHEMISTRY ANALYZER
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 “clinitek”. A notice may cover another product or only some lots: read it to see what it covers.
- CLINITEK Status System - Urine Chemistry Analyzer (2020-02-10)February 28, 2020 · Medical devices · Medical devices · Type III
- Clinitek Atlas Automated Urine Chemistry SystemSeptember 11, 2017 · Medical devices · Type III
- CLINITEK Status+ (2016-01-25)February 12, 2016 · Medical devices · Medical devices · Type III
- CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM- CONTROL STRIPS (2016-01-26)February 8, 2016 · Medical devices · Medical devices · Type III
- CLINITEK NOVUS 10 AND PRO 10 URINALYSIS CASSETTES (2015-12-21)January 14, 2016 · Medical devices · Health products · Type III
- CLINITEK NOVUS ANALYZER (WITH RACK) (2015-07-02)July 17, 2015 · Medical devices · Health products · Type III
- CLINITEK Novus Automated Urine Chemistry Analyzers (2015-01-15)February 16, 2015 · Medical devices · Health products · Type III
- CLINITEK Novus Automated Urine Chemistry Analyzers (2015-01-28)February 16, 2015 · Medical devices · Health products · Type III
- Clinitek Novus Automated Urine Chemistry Analyzer (with and without rack handler) (2014-11-10)November 20, 2014 · Medical devices · Medical devices · Type III
- Clinitek Status System-Urine Chemistry Analyzer (2014-09-24)October 9, 2014 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.