SC1 Handheld Ultrasound Imaging system (Model: SC1)

FDA 510(k)

FDA Class 2 ·Radiology

SC1 Handheld Ultrasound Imaging System (Model: SC1)

FDA 510(k)

FDA Class 2 ·Radiology

SC1 Handheld ultrasound imaging system

Basic UDI-DI

EU MDD · Eu Md Class 2a ·FCU Co., Ltd.·1 device

eZono AG

Authorized representative

🇩🇪 Germany·1 Manufacturer·1 Device

1434-MDD-365/2021

Certificate

MDD Annex II (excluding section 4)·FCU Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

eZono AG

Importer

🇩🇪 Germany·2 Manufacturers

ACU 1060.1

FDA registration

INSTRUMENTATION INDUSTRIES, INCORPORATED·1 product·🇺🇸 United States

ACU-MICRO-NEEDLE

FDA registration

ACUDERM, INC.·1 product·🇺🇸 United States

ACU-PUNCH

FDA registration

ACUDERM, INC.·1 product·🇺🇸 United States

ICU Medical, Inc.

Manufacturer

🇺🇸 United States·1 Importer

ICU Medical, Inc.

Manufacturer

🇺🇸 United States·2 Basic UDI-DIs·55 Devices·1 Importer

ICU Medical Australia Pty Limited

Manufacturer

🇦🇺 Australia

Handan FCH Medical Technology Co.,Ltd.

Manufacturer

🇨🇳 China·2 Basic UDI-DIs·7 Devices

Acu Loc 2 System

FDA registration

ACUMED LLC·2 products·🇺🇸 United States

Acu-Strap Motion Sickness Band: Acu-Life, EzyDose, Flents; 400198, HK400198

FDA registration

APOTHECARY PRODUCTS, LLC.·1 product·🇺🇸 United States

KIT SPANISH 560P HIGH DEF CCU

FDA registration

SMITH & NEPHEW INC.·1 product·🇺🇸 United States

KIT SPANISH 560P HIGH DEF CCU

FDA registration

SMITH & NEPHEW INC.·1 product·🇺🇸 United States

Acu-Punch

FDA registration

ACUDERM, INC.·1 product·🇺🇸 United States

ACU-EVAC

FDA registration

ACUDERM, INC.·1 product·🇺🇸 United States

GI CCU

FDA registration

KARL STORZ SE & CO. KG·1 product·🇩🇪 Germany