Medical device licence · 68787 · Class 2
VERSATREK SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 7, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 68787
- Licence holder
- Remel Inc.Lenexa, KS, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 7, 2005
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VERSATREK 528 CONNECTOR
- VERSATREK 528 MYCO
- VERSATREK 528 MYCO AS
- VERSATREK 528 MYCO GS
- VERSATREK 528 MYCO PVNA
- VERSATREK 528 MYCO PZA KIT
- VERSATREK 528 MYCO SUSCEPTIBILITY KIT
- VERSATREK 528 REDOX (MEDIA)
- VERSATREK 528 REDOX EZ DRAW (MEDIA)
- VERSATREK 528 W/14/16/18/20/22 DRAWERS
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 “versatrek”. A notice may cover another product or only some lots: read it to see what it covers.
- VERSATREK AUTOMATED MICROBIAL DETECTION SYSTEM (528 MODEL) (2015-05-26)July 9, 2015 · 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.