Medical device licence · 65176 · Class 4
EMBOSPHERE MICROSPHERES
Yes: licensed in Canada
Licence status Issued (active); first licensed July 14, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 65176
- Licence holder
- Biosphere Medical S.A.Rockland, MA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- July 14, 2004
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EMBOSPHERE MICROPSHERES - SYRINGE
- 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.