Medical device licence · 92004 · Class 2
MADSEN CAPELLA 2
Yes: licensed in Canada
Licence status Issued (active); first licensed September 24, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92004
- Licence holder
- Intelligent Hearing Systems Corp.Miami, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 24, 2013
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MADSEN CAPELLA 2 - 10D OAE PROBE
- MADSEN CAPELLA 2 - CAPELLA 2 SYSTEM SOFTWARE
- MADSEN CAPELLA 2 - OAE STARTER KIT
- MADSEN CAPELLA 2 - SMART OAELITE BOARD
- MADSEN CAPELLA 2 - SMART OAELITE BOX
- MADSEN CAPELLA 2 - SOFTWARE MEDIA WITH OTOSUITE
- MADSEN CAPELLA 2 - TEST CAVITY
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 “madsen”. A notice may cover another product or only some lots: read it to see what it covers.
- Madsen® AccuScreen® TEOAE/DPOAE/ABR ProbeMarch 4, 2026 · Ear, nose and throat · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.