Medical device licence · 112224 · Class 3
ELISA 300 - 500
Yes: licensed in Canada
Licence status Issued (active); first licensed November 18, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 112224
- Licence holder
- Lowenstein Medical Innovation Gmbh & Co. KgSteinbach, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- November 18, 2024
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ELISA 300 CANADA
- ELISA 500 CANADA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.