Vitreq B.V.

MDA 0309 - Active non-implantable ophthalmologic devices - CryoTreQ, Phacoemulsification/ Vitrectomy System with and without laser

MDD Confirmation Letter

Design, Development and Manufacturing of phacoemulsification / vitrectomy system, sterile vitrectomy probes, sterile ophthalmic surgical prodecure pack, sterile ophthalmic cannulation sets, sterile ophthalmic cannulation sets, sterile viscous fluid injection / extraction tool, sterile laser probes, sterile light fibers, sterile fluid applicators, sterile backflush instruments, reusable backflush instruments, sterile vitrectomy lenses, sterile irrigation/aspiration cannulas, sterile forceps, sterile scissors, reusable forceps, reusable scissors, reusable light source adaptors, reusable orbital depressor, as intended for ophthalmic surgery. Installation of phacoemulsification / vitrectomy system. Servicing of phacoemulsification / vitrectomy system, reusable forceps and reusable scissiors, intended for ophthalmic surgery AUS (a), BRA, CAN, JPN, USA (a,b,c,d)

Design, Development and Manufacturing of phacoemulsification / vitrectomy system, sterile vitrectomy probes, sterile ophthalmic surgical prodecure pack, sterile ophthalmic cannulation sets, sterile viscous fluid injection / extraction tool, sterile laser probes, sterile light fibers, sterile fluid applicators, sterile backflush instruments, reusable backflush instruments, sterile vitrectomy lenses, sterile irrigation/aspiration cannulas, sterile forceps, sterile scissors, reusable forceps, reusable scissors, reusable light source adaptors, reusable orbital depressor, as intended for ophthalmic surgery. Installation of phacoemulsifiction / vitrectomy system. Servicing of phacoemulsifiction / vitretomy system, reusable forcreps and reusable scissiors, intended for ophthalmic surgery.

Design, Development and Manufacturing of phacoemulsification / vitrectomy system, sterile vitrectomy probes, sterile ophthalmic surgical prodecure pack, sterile ophthalmic cannulation sets, sterile ophthalmic cannulation sets, sterile viscous fluid injection / extraction tool, sterile laser probes, sterile light fibers, sterile fluid applicators, sterile backflush instruments, reusable backflush instruments, sterile vitrectomy lenses, sterile irrigation/aspiration cannulas, sterile forceps, sterile scissors, reusable forceps, reusable scissors, reusable light source adaptors, reusable orbital depressor, as intended for ophthalmic surgery. Installation of phacoemulsification / vitrectomy system. Servicing of phacoemulsification / vitrectomy system, reusable forceps and reusable scissiors, intended for ophthalmic surgery AUS (a), BRA, CAN, JPN, USA (a,b,c,d)