Medical device licence · 96340 · Class 3
EVA
Yes: licensed in Canada
Licence status Issued (active); first licensed January 4, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96340
- Licence holder
- D.O.R.C Dutch Ophthalmic Research Center (International) B.V.Zuidland, Netherlands
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 4, 2016
- Devices covered
- 32
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIMANUAL IRRIGATION/ASPIRATION SET
- CURVED TIP FOR UNIVERSAL I/A HANDPIECE
- CURVED TIP WITH SILICONE SLEEVE FOR UNIVERSAL I/A HANDPIECE
- DIRECTIONAL LASER PROBE
- DISPOSABLE EVA ACCESSORY SET
- DISPOSABLE EVA AIR FLUID DUAL TUBING
- DISPOSABLE EVA DOUBLE IRRIGATION LINE
- DISPOSABLE EVA GRAVITY INPUT SET
- DISPOSABLE EVA IRRIGATION AND ASPIRATION TUBING
- DISPOSABLE EVA VGPC INPUT SET
- DISPOSABLE HIGH SPEED CUTTER
- DISPOSABLE HIGH SPEED TDC CUTTER
- DISPOSABLE INFUSION SLEEVE
- DISPOSABLE TUBINGS
- EVA, ANTERIOR MACHINE
- EVA, COMBINED MACHINE
- FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE
- ILLUMINATED LASER PROBE
- ILLUMINATED STEPPED LASER PROBE
- IRRIGATION SLEEVE
- KIT FOR SUBRETINAL INJECTION OF BSS
- LASER PROBE
- PHACO FRAGMENTATION NEEDLE, TITANIUM INCL. NEEDLE WRENCH
- SAFETY FILTER
- STEPPED LASER PROBE
- STRAIGHT PHACO NEEDLE
- STRAIGHT TIP FOR UNIVERSAL I/A HANDPIECE
- TEST CHAMBER FOR PHACO HANDPIECE
- TRIPLE STEP ANGLED FLARED PHACO NEEDLE
- TRIPLE STEP FLARED PHACO NEEDLE
- UNIVERSAL I/A HANDPIECE
- VFI PACK FOR SILICONE OIL SYRINGES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.