22 results · 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