16 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: Israel
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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
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Eu Md Class 1
·Active Optical Systems Ltd·On the market·10 countries
Spirit Trio
Device
EU MDR
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Eu Md Class 1
·Active Optical Systems Ltd·On the market
Extra 818
Device
EU MDR
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Eu Md Class 1
·Active Optical Systems Ltd·On the market·15 countries
Sheerwave
Device
EU MDD
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Eu Md Class 2a
·Active Optical Systems Ltd·On the market·16 countries
Extra
Device
EU MDD
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Eu Md Class 2a
·Active Optical Systems Ltd·On the market·24 countries
cFactor
Device
EU MDD
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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
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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