Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly

CRAD-RO SRL

Importer

🇷🇴 Romania

Pediatric Ventricular Assist Device

FDA classification

Pediatric Ventricular Assist Device

Bio-Rad France

Importer

🇫🇷 France

CE 641606

Certificate

MDD Annex II (excluding section 4)·Rad Source Technologies Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

Gauging

FDA classification

FDA Not Classified ·Gauging

Bio-Rad Laboratories B.V.

Importer

🇳🇱 Netherlands

Bio-Rad Norway AS

Importer

🇳🇴 Norway

HX 1037243-1

Certificate

IVDR QMS·Bio-Rad Medical Diagnostics GmbH·TÜV Rheinland LGA Products GmbH

Bio-Rad France

System producer

🇫🇷 France

Tri Rad Medical GmbH

Authorized representative

🇩🇪 Germany·1 Manufacturer·14 Devices

Seegene Germany GmbH

Importer

🇩🇪 Germany·5 Manufacturers

Suture Hook

FDA registration

Sterigenics US, LLC·1 product·🇺🇸 United States

Suture Hook

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

Suture Hook

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

Suture Hook

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

Suture Hook

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

Suture Hook

FDA registration

Sterigenics Radiation Technologies IN, Inc·1 product·🇺🇸 United States

Suture Hook

FDA registration

Sterigenics U.S. LLC·1 product·🇺🇸 United States

Suture Hook

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States