33 results
·
10ms
·
Sources: EU EUDAMED, US FDA
Atrotech Oy
Manufacturer
🇫🇮 Finland·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH
Aleva Neurotherapeutics SA
Manufacturer
🇨🇭 Switzerland·13 Basic UDI-DIs·13 Devices·DEKRA Certification B.V.
Atrostim PNS
Device
EU AIMDD
·
Eu Aimdd Class
·Atrotech Oy·On the market·32 countries
directSTIM 24-channel Implantable Pulse Generator
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM 12-electrode lead
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Port Plug
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Power Cord
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Adjustable Harness
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Charging Paddle
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Magnet
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Tunneling Tool
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Trial Cable
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM External Pulse Generator
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Patient Programmer Charger kit
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Clinician Programmer
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM 12-connector extension
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
TÜV SÜD Product Service GmbH
Notified body
🇩🇪 Germany·628 Manufacturers·12418 Basic UDI-DIs
Atrostim Phrenic Nerve Stimulator
Basic UDI-DI
EU AIMDD
·
Eu Aimdd Class
·Atrotech Oy·1 device
I7 17 05 33625 016
Certificate
AIMDD Annex II (excluding section 4)·Atrotech Oy·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
Port Plug
Basic UDI-DI
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·1 device