Medical device licence · 15548 · Class 4
EMBOSPHERE MICROSPHERES
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed January 7, 2000; ended March 12, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 15548
- Licence holder
- Biosphere Medical S.A.Rockland, MA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Single Device
- First licensed
- January 7, 2000
- Ended
- March 12, 2004
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EMBOSPHERE MICROSPHERES - VIALS
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 “embosphere”. A notice may cover another product or only some lots: read it to see what it covers.
- Embosphere® Microspheres-SyringeAugust 19, 2026 · Neurology · Sterility · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.