14 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Finland
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Lifa Air Medical face mask type I red, 1 pc
Device
EU MDR
·
Eu Md Class 1
·Lifa Air Oy Ltd·On the market·30 countries
Lifa Air Medical face mask type I black, 1 pc
Device
EU MDR
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Eu Md Class 1
·Lifa Air Oy Ltd·On the market·30 countries
Lifa Air Medical face mask type IIR dog, 1 pc
Device
EU MDR
·
Eu Md Class 1
·Lifa Air Oy Ltd·On the market·30 countries
Lifa Air Medical face mask type IIR black, 1 pc
Device
EU MDR
·
Eu Md Class 1
·Lifa Air Oy Ltd·On the market·30 countries
Lifa Air Medical face mask type IIR blue, 1 pc
Device
EU MDR
·
Eu Md Class 1
·Lifa Air Oy Ltd·On the market·30 countries
Lifa Air Medical face mask type IIR cat, 1 pc
Device
EU MDR
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Eu Md Class 1
·Lifa Air Oy Ltd·On the market·30 countries
Lifa Air Medical face mask type IIR yellow, 1 pc
Device
EU MDR
·
Eu Md Class 1
·Lifa Air Oy Ltd·On the market·30 countries
CR-03-1087-817-23
Certificate
MDR QMS·Nexstim Plc·Eurofins Electric & Electronics Finland Oy
EUFI29-21000160-S
Certificate
MDD Annex II (excluding section 4)·Nexstim Plc·Eurofins Electric & Electronics Finland Oy·3 Basic UDI-DIs
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Enforcement
Class II
·Ongoing·Nexstim PLC·June 14, 2017
Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Enforcement
Class II
·Ongoing·Nexstim PLC·June 14, 2017
Mekalasi Oy
Importer
🇫🇮 Finland·10 Manufacturers
Vingmed Oy
Importer
🇫🇮 Finland·7 Manufacturers
Plandent Oy
Importer
🇫🇮 Finland·43 Manufacturers