Medical device licence · 80015 · Class 2
BIOPSY NEEDLE
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed June 19, 2009; ended July 9, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 80015
- Licence holder
- Gallini S.R.L.Mantova, MO, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 19, 2009
- Ended
- July 9, 2015
- Devices covered
- 29
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACRI
- ACRI R
- ADVANCED BRELL
- BIOMID
- BIOSPRING
- BRELL
- BRIGHTFLEX
- ECHOMASTER
- EVI TRAP
- EVOLUTION
- FRANZEEN
- GCO BIOPSY NEEDLES
- HEPA-IBI
- IBI
- ISAN
- MCA
- MCA-U
- NEEDLE FOR CHORIAL VILLI
- PAN ETA
- PAN, CHIBA NEEDLE
- SOFT TOUCH
- SPEEDCUT
- TEM
- TR
- TR-V
- TX
- TZ
- VERTEBRO TRAP
- WESTCOTT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.