Customers and certificates

Vitreq B.V.

Business Sector:
Non-active non-implantable ophthalmologic devices, Non-active ophthalmologic devices, General non-active, non-implantable medical devices
Reference No.:
527668
Certified according to :

Medical Devices VO (EU) 2017/745

Download certificate : 05.06.2025 englisch

Scope:

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

Scope:

MDD Confirmation Letter

Certified according to :
Scope:

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)

Certified according to :
Scope:

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.

Certified according to :

ISO 13485:2016 (MDSAP Audit Model Edition 2)

This certification belongs to the parent company 527668 Vitreq B.V.

Scope:

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)