Steady Pro

Device

EU MDR · Eu Md Class 1 ·KOELIS·On the market·20 countries

Disposable guides KDNG00

FDA 510(k)

FDA Class 2 ·Radiology

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range

FDA 510(k)

FDA Class 2 ·Radiology

UROSTATION 3D PROSTATE SUITE

FDA 510(k)

FDA Class 2 ·Radiology

TRINITY/3D PROSTATE SUITE

FDA 510(k)

FDA Class 2 ·Radiology

REUSABLE GUIDE

FDA 510(k)

FDA Class 2 ·Radiology

TRINITY

FDA 510(k)

FDA Class 2 ·Radiology

3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION

FDA 510(k)

FDA Class 2 ·Radiology

Mechanical articulated arm

Basic UDI-DI

EU MDR · Eu Md Class 1 ·KOELIS·4 devices

PERINE GRID 14G

Basic UDI-DI

EU MDR · Eu Md Class 1 ·KOELIS·1 device

Perine Adapter

Basic UDI-DI

EU MDR · Eu Md Class 1 ·KOELIS·1 device

Z-LOCK

Basic UDI-DI

EU MDR · Eu Md Class 1 ·KOELIS·1 device

KOELIS SAS

Importer

🇫🇷 France·1 Manufacturer

Koel OTC

FDA registration

ISUNIYE LLC·1 product·🇺🇸 United States

Vera Wang

FDA UDI

Kenmark Optical, Inc.·00715317998277·Keely Gold Spectacle

Vera Wang

FDA UDI

Kenmark Optical, Inc.·00715317998253·Keely Black Spectacle

Vera Wang

FDA UDI

Kenmark Optical, Inc.·00715317998260·Keely Gold Spectacle

Vera Wang

FDA UDI

Kenmark Optical, Inc.·00715317998246·Keely Black Spectacle

Vera Wang

FDA UDI

Kenmark Optical, Inc.·00715317998222·Keely Gunmetal Spectacle

Vera Wang

FDA UDI

Kenmark Optical, Inc.·00715317998239·Keely Gunmetal Spectacle