Medical device licence · 79032 · Class 2
MADSEN ASTERA AUDIOMETER
Yes: licensed in Canada
Licence status Issued (active); first licensed February 10, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79032
- Licence holder
- Natus Medical Denmark ApsTaastrup, Denmark
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 10, 2009
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACP ASTER 2
- BC-2 BONE CONDUCTOR WITH HEADBAND
- BC-2 RECEIVER
- MADSEN ASTERA
- MICROPHONE WITH TABLE STAND (JACK)
- OTOSUITE
- PATIENT RESPONDER AUDIOMETER
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.