22 results
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119ms
·
Sources: EU EUDAMED, US FDA
EXINI Diagnostics AB
Manufacturer
🇸🇪 Sweden·4 Basic UDI-DIs·4 Devices
PYLARIFY AI
FDA registration
EXINI DIAGNOSTICS AB·1 product·🇸🇪 Sweden
aBSI
FDA registration
EXINI DIAGNOSTICS AB·1 product·🇸🇪 Sweden
EXINI Bone
FDA UDI
Exini Diagnostics AB·07350002333037·EXINI bone is a stand alone software intended f...
PYLARIFY AI
FDA UDI
Exini Diagnostics AB·07350002336014·PYLARIFY AI is a software only medical device t...
aBSI
FDA UDI
Exini Diagnostics AB·07350002332030·The aBSI is a software-only medical device that...
EXINI
FDA UDI
Exini Diagnostics AB·07350002331033·EXINI is intended to be used by trained health-...
PYLARIFY AI
FDA UDI
Exini Diagnostics AB·07350002336021·PYLARIFY AI is intended to be used by healthcar...
aPROMISE
FDA UDI
Exini Diagnostics AB·07350002335017·aPROMISE is a softwareonly medical device that ...
aPROMISE
FDA UDI
Exini Diagnostics AB·07350002337028·PYLARIFY AI is intended to be used by healthcar...
PYLCLARI AI
Device
EU MDR
·
Eu Md Class 2a
·EXINI Diagnostics AB·On the market·16 countries
aBSI
Device
EU MDR
·
Eu Md Class 2a
·EXINI Diagnostics AB·On the market·8 countries
aPROMISE
Device
EU MDR
·
Eu Md Class 2a
·EXINI Diagnostics AB·On the market·15 countries
EXINI Bone
Device
EU MDR
·
Eu Md Class 2a
·EXINI Diagnostics AB·On the market·14 countries
EXINI
FDA 510(k)
FDA Class 2
·Radiology
aPROMISE
FDA 510(k)
FDA Class 2
·Radiology
aBSI
FDA 510(k)
FDA Class 2
·Radiology
aPROMISE X
FDA 510(k)
FDA Class 2
·Radiology
PYLCLARI AI
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·EXINI Diagnostics AB·1 device
aBSI
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·EXINI Diagnostics AB·1 device