Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER MODELS MFL5000 SHOCK WAVE LITHOTRIPTER

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER, MODEL HM3

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER COMPACT

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)

MICOR Lens Fragmentation System

FDA 510(k)

FDA Class 2 ·Ophthalmic

xPORT 304 (miCOR) System Lens Fragmentation System

FDA 510(k)

FDA Class 2 ·Ophthalmic

miCOR System Lens Fragmentation System

FDA 510(k)

FDA Class 2 ·Ophthalmic

xPORT Lens Fragmentation System

FDA 510(k)

FDA Class 2 ·Ophthalmic

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

FDA 510(k)

FDA Class 2 ·Ophthalmic

xPORT S Lens Fragmentation System

FDA 510(k)

FDA Class 2 ·Ophthalmic

Luxus Lebenswelt GmbH

Authorized representative

🇩🇪 Germany·191 Manufacturers·2068 Devices

Shanghai International Holding Corp. GmbH(Europe)

Authorized representative

🇩🇪 Germany·637 Manufacturers·33064 Devices

Murine Bright and Moist

Basic UDI-DI

EU MDD · Eu Md Class 3 ·Medtech Products Inc·1 device

EPT 0477.MDD.19/3485

Certificate

MDD Annex II (excluding section 4)·Medtech Products Inc·Eurofins Product Testing Italy S.r.l.·1 Basic UDI-DI

EPT 0477.MDD.19/3484

Certificate

MDD Annex II Section 4·Medtech Products Inc·Eurofins Product Testing Italy S.r.l.·1 Basic UDI-DI

Dornier MedTech Systems GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer

PULMOJ S.R.L.

Importer

🇮🇹 Italy·3 Manufacturers

Asahi Kasei Medical Europe GmbH

Authorized representative

🇩🇪 Germany·3 Manufacturers·34 Devices

Elara Pharmaservices Europe Ltd

Authorized representative

🇮🇪 Ireland·8 Manufacturers·53 Devices

Dornier MedTech Italia s.r.l.

Importer

🇮🇹 Italy·2 Manufacturers