OVX - BEUDAMED

FDA Pre-Market Approval

FDA Class 3 ·Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon

Importer

🇩🇪 Germany

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON ULTIMATE DUAL PACK, AND HEALON DUET

FDA Pre-Market Approval

FDA Class 3 ·Sodium Hyaluronate Ophtalmic Viscoelastic Devices (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack

FDA Pre-Market Approval

Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack

FDA Pre-Market Approval

FDA Class 3 ·Sodium Hyaluronate OphthalmicViscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dual

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Spectranetics Corporation·1 device

Authorized representative

🇩🇪 Germany·2 Manufacturers

FDA Pre-Market Approval

FDA Class 3 ·Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dua

FDA Pre-Market Approval

FDA Class 3 ·Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack, Healon GV PRO Sodium Hya

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Philips Ultrasound LLC·22 devices

FDA 510(k)

FDA Class 2 ·Cardiovascular

FDA 510(k)

FDA Class 2 ·Cardiovascular

FDA Pre-Market Approval

FDA Class 3 ·Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon® PRO, Healon GV® PRO, Healon5® PRO and Healon® Duet PRO