830 to 860 Upgrade

FDA UDI

G E MEDICAL SYSTEMS ISRAEL LTD.·00840682145473·

M.2025.MDR.1062 - 1

Certificate

MDR Technical Documentation·DK Medical Technology Co., Ltd.·UDEM Adriatic d.o.o.·1 Basic UDI-DI

Cardiac Marker Multi Control

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

JK Surgical Sp. z o. o.

Importer

🇵🇱 Poland·2 Manufacturers

Bureau Medica Intercert DK

Authorized representative

🇩🇰 Denmark·2 Manufacturers

Encompass™ SRS Fibreplast™ System

FDA UDI

Qfix·10841962111390·Encompass Fibreplast Variable Perf Open View Ma...

Encompass™ SRS Fibreplast™ System

FDA UDI

Qfix·10841962111406·Encompass Head Only Open View Thermoplastic System

Encompass™

FDA UDI

Qfix·10841962109496·Encompass SRS MRI Standalone Device with E0 hea...

Encompass™ SRS Fibreplast™ System

FDA UDI

Qfix·10841962109519·Encompass Fibreplast Variable Perf Open View Ma...

Encompass™ SRS Fibreplast™ Anterior Mask

FDA UDI

Qfix·10841962110928·Encompass™ Fibreplast® Variable Perf Open View ...

ZiFix™

FDA UDI

Qfix·10841962110508·ZiFix™ Abdominal/Thoracic Motion Control System

Encompass™ SRS Fibreplast® Anterior Mask

FDA UDI

Qfix·10841962118726·Encompass™ Fibreplast® Variable Perf Open View ...

Encompass™ SRS Fibreplast™ System

FDA UDI

Qfix·10841962109526·Encompass Head Only Open View Thermoplastic System

ZiFix Traverse™

FDA UDI

Qfix·10841962111123·ZiFix Traverse™ Abdominal/Thoracic Motion Contr...

Encompass™

FDA UDI

Qfix·10841962109502·kVue Encompass SRS Insert with E0 headrest & ha...

SRS MR Adapter

FDA UDI

Qfix·10841962110775·SRS MR Adapter for Portrait™ and S-Type Devices

Encompass™

FDA UDI

Qfix·10841962109489·Encompass SRS Stand Alone Device with E0 headre...

SRS Adapter

FDA UDI

Qfix·10841962110768·SRS Adapter for Portrait™ and S-Type Devices

Agfa NV

Importer

🇧🇪 Belgium·8 Manufacturers

Symphony™ BoS™

FDA UDI

Qfix·10841962110447·Symphony™ Bos™ Transfer Device