94 results
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25ms
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Sources: EU EUDAMED, US FDA
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Country: Spain
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Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·January 31, 2024
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·February 21, 2024
Halotech DNA
Manufacturer
🇪🇸 Spain·5 Basic UDI-DIs·5 Devices
ovoselect
Device
EU IVDD
·
Eu Ivd General
·Halotech DNA·On the market
oxiSperm II
Device
EU IVDD
·
Eu Ivd General
·Halotech DNA·On the market
halosperm G2
Device
EU IVDD
·
Eu Ivd General
·Halotech DNA·On the market
halosperm
Device
EU IVDD
·
Eu Ivd General
·Halotech DNA·On the market
dyn-halosperm
Device
EU IVDD
·
Eu Ivd General
·Halotech DNA·On the market
ANA Advanced Neurovascular Access™
Device
EU MDD
·
Eu Md Class 3
·ANACONDA BIOMED, S.L.·On the market·1 country
ovoselect
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Halotech DNA·1 device
oxiSperm II
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Halotech DNA·1 device
dyn-halosperm
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Halotech DNA·1 device
halosperm G2
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Halotech DNA·1 device
halosperm
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Halotech DNA·1 device
ANA Advanced Neurovascular Access™
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·ANACONDA BIOMED, S.L.·1 device
Ana del Campo Mateos
Authorized representative
🇪🇸 Spain·1 Manufacturer
Regulatory Quality Management Information Source AREU, S.L.U
Authorized representative
🇪🇸 Spain·8 Manufacturers·51 Devices
AF Pharma Service Europe SL
Authorized representative
🇪🇸 Spain·51 Manufacturers·881 Devices
ALTRIS EUROPE, SOCIEDAD LIMITADA
Authorized representative
🇪🇸 Spain·1 Manufacturer·1 Device
SAS Exclusivas Dentales S.L.
Authorized representative
🇪🇸 Spain·1 Manufacturer