Medical device licence · 35481 · Class 3
BREAST TISSUE MARKERS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 11, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 35481
- Licence holder
- Senorx Inc.Tempe, AZ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- January 11, 2002
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GEL MARK ULTRA BREAST TISSUE MARKER FOR ENCOR
- GEL MARK ULTRACOR BREAST TISSUE MARKER
- SENOMARK BREAST TISSUE MARKER FOR ATEC
- SENOMARK BREAST TISSUE MARKER FOR ENCOR
- SENOMARK BREAST TISSUE MARKER FOR MAMMOTOME
- SENOMARK ULTRACOR MRI BREAST TISSUE MARKER
- ULTRACOR BREAST TISSUE MARKER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.