8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Micromed S.p.A.
Manufacturer
🇮🇹 Italy·2 Basic UDI-DIs·2 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
BRAIN QUICK SOFTWARE
Device
EU MDR
·
Eu Md Class 2b
·Micromed S.p.A.·On the market·32 countries
VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES
Device
EU MDD
·
Eu Md Class 2b
·Micromed S.p.A.·On the market·32 countries
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
FDA Enforcement
Class II
·Ongoing·Micromed S.p.A.·June 17, 2026
BRAIN QUICK SOFTWARE
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·Micromed S.p.A.·1 device
BRAIN QUICK SOFTWARE
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Micromed S.p.A.·1 device
Micromed S.p.A.
Importer
🇮🇹 Italy
1286/MDD
Certificate
MDD Annex II (excluding section 4)·Micromed S.p.A.·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·1 Basic UDI-DI