94 results · 25ms · Sources: EU EUDAMED, US FDA

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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