Medical device licence · 104763 · Class 3
SMARTXIDE2
Yes: licensed in Canada
Licence status Issued (active); first licensed June 12, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104763
- Licence holder
- Deka M.E.L.A. S.R.L.Calenzano, FI, Italy
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 12, 2020
- Devices covered
- 35
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 8" HANDPIECE
- BOX FOR MICROSCAN
- CO2 5" HANDPIECE
- COLLIMATED HANDPIECE
- COLPOSCAN
- DENTAL HANDPIECE
- DIODE LASER 50W 940NM ACCESSORIES
- DIODE LASER 50W 980NM ACCESSORIES
- ENDONASAL PROBE KIT
- ENDOSCAN SMARTXIDE2
- FIXED FOCUS LENS ASSEMBLY
- FL 1.5" HANDPIECE
- FL 2" HANDPIECE
- FL 4" HANDPIECE
- FL 7" HANDPIECE
- FOOTSWITCH
- HANDPIECE
- HANDPIECE FOCAL 2" BK, WITH STRAIGHT AND 120 DEGREE TIP
- HISCAN SCAR 3
- HISCAN SURGICAL
- INTERLOCK CONNECTOR
- ITT-STORZ COUPLER
- LAPARO FOCAL ASSEMBLY
- LIPOLYSIS STRAIGHT CANNULA 1*100MM
- LIPOLYSIS STRAIGHT CANNULA 1*150MM
- LIPOLYSIS STRAIGHT CANNULA 1*200MM
- LIPOLYSIS STRAIGHT CANNULA 1*250MM
- MICROMANIPULATOR EASYSPOT HYBRID
- MICROSCAN SURGICAL
- SMARTXIDE2 C60
- SMARTXIDE2 C60H
- SMARTXIDE2 C80
- SMARTXIDE2 C80H
- SMARTXIDE2 TRIO C60H
- STRAIGHT CANNULA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.