Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM

9727-2017-CE-RGC-NA-PS

Certificate

MDD Annex V·TRONJEN MEDICAL TECHNOLOGY INC.·DNV Product Assurance AS·5 Basic UDI-DIs

Master-Vu A-Scan Ophthalmic Ultrasound System

FDA UDI

SONOMED, INC.·00896100002101·The Master-Vu A-Scan Ophthalmic Ultrasound Syst...

VuPad Ophthalmic Ultrasound System

FDA UDI

SONOMED, INC.·00896100002125·The VuPad B-Scan Ophthalmic Ultrasound System i...

VuPad Ophthalmic Ultrasound System

FDA UDI

SONOMED, INC.·00896100002170·The VuPad A Ophthalmic Ultrasound System is a p...

Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit

FDA UDI

INFRAREDX, INC.·00857595006180·The Infraredx Clarispro™ HD-IVUS Imaging Cathet...

TVC Insight™

FDA UDI

INFRAREDX, INC.·00857595006203·Insight Catheter™ Kit The TVC Insight Catheter...

POLLOGEN LEGEND

FDA UDI

POLLOGEN LTD·07290016586008·The Pollogen Legend+ system is intended for der...

International Associates Auditing & Certification Limited

Authorized representative

🇮🇪 Ireland·46 Manufacturers·161 Devices

ORTHO-REHA Neuhof GmbH

Importer

🇩🇪 Germany·17 Manufacturers

TVC Insight™

FDA UDI

INFRAREDX, INC.·00857595006210·Insight Hydrophilic Catheter™ Kit The TVC Insi...

Dualpro™ IVUS+NIRS Imaging Catheter Kit

FDA UDI

INFRAREDX, INC.·00857595006234·The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TV...

Makoto Intravascular Imaging System™

FDA UDI

INFRAREDX, INC.·00857595006432·The Makoto Intravascular Imaging System™ (TVC-M...

TVC Insight XB™

FDA UDI

INFRAREDX, INC.·00857595006227·Insight XB™ Catheter Kit The TVC Insight XB™ Ex...

Eurolink Europe Compliance Limited

Authorized representative

🇮🇪 Ireland·35 Manufacturers·252 Devices

Maxcert Eurep

Authorized representative

🇩🇪 Germany·65 Manufacturers·8 Devices

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices

CMC Medical Devices & Drugs SL

Authorized representative

🇪🇸 Spain·698 Manufacturers·11260 Devices