16 results · 17ms · Sources: EU EUDAMED, US FDA

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Active Optical Systems Ltd

Manufacturer
🇮🇱 Israel·6 Basic UDI-DIs·6 Devices·MDC MEDICAL DEVICE CERTIFICATION GMBH and MDC MEDICAL DEVICE CERTIFICATION GMBH

Body Shape

Device
EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·On the market·10 countries

Spirit Trio

Device
EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·On the market

Extra 818

Device
EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·On the market·15 countries

Sheerwave

Device
EU MDD · Eu Md Class 2a ·Active Optical Systems Ltd·On the market·16 countries

Extra

Device
EU MDD · Eu Md Class 2a ·Active Optical Systems Ltd·On the market·24 countries

cFactor

Device
EU MDD · Eu Md Class 2a ·Active Optical Systems Ltd·On the market·12 countries

SMV DSX New Line, System, Tomography, Computed, Emission

FDA Enforcement
Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 21, 2026

Spirit

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·1 device

Body Shape

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·1 device

Optima

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Active Optical Systems Ltd·1 device

Spirit

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Active Optical Systems Ltd·1 device

Extra

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Active Optical Systems Ltd·1 device

Extra

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Active Optical Systems Ltd·1 device

D1096300016

Certificate
MDD Annex V·Active Optical Systems Ltd·MDC MEDICAL DEVICE CERTIFICATION GMBH·2 Basic UDI-DIs

07290016727043

Certificate
MDD Annex V·Active Optical Systems Ltd·MDC MEDICAL DEVICE CERTIFICATION GMBH·1 Basic UDI-DI