Custom MedLabel Pack - Pack Name:Marker, Ruler & Labels Revision 5

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

Custom MedLabel Pack - Pack Name:Marker, Ruler & Labels Revision 5

FDA registration

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

Qualrep Services B.V.

Authorized representative

🇳🇱 Netherlands·24 Manufacturers·43 Devices

Optoacoustic Imaging System

FDA Pre-Market Approval

FDA Class 3 ·Imagio® Breast Imaging system

Optoacoustic Imaging System

FDA Pre-Market Approval

FDA Class 3 ·Imagio Breast Imaging System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Bone Void Filler, Syringe

FDA classification

FDA Not Classified ·Bone Void Filler, Syringe

System, In-Office Tinting, Contact Lenses

FDA classification

FDA Class 2 ·System, In-Office Tinting, Contact Lenses

General Laparoscopic Power Morcellation Containment System

FDA classification

FDA Class 2 ·General Laparoscopic Power Morcellation Containment System

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·QDOT MICRO™ System

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)

Digital Prismatic Correction

FDA classification

FDA Class 1 ·Digital Prismatic Correction

Field Generator Positioning Device

FDA classification

FDA Class 1 ·Field Generator Positioning Device

C-Arm Fluoroscopic X-Ray System

FDA classification

FDA Class 2 ·C-Arm Fluoroscopic X-Ray System

AI-Libre Urinalysis System

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·URIT Medical Electronic Co.,Ltd.·3 devices

mini OTSC System Set

FDA UDI

Ovesco Endoscopy AG·04260206311119·The mini OTSC System extends the OTSC System by...

mini OTSC System Set

FDA UDI

Ovesco Endoscopy AG·04260206311249·The mini OTSC System extends the OTSC System by...

SoundBite

FDA UDI

Sonitus Medical?Shanghai?Co., ltd.·06972667660313·The SoundBite Hearing System by Sonitus Medical...

mini OTSC System Set

FDA UDI

Ovesco Endoscopy AG·04260206311102·The mini OTSC System extends the OTSC System by...