M Dialysis AB
SE-MF-000017466 · Sweden · Stockholm
M Dialysis AB is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 21 |
|---|---|
| other | 3 |
Most frequent device types declared: Linear Microdialysis Catheter, Microdialysis Catheter, Intravenous Microdialysis Catheter, Perfusion Fluid, Microdialysis Pump.
Among these devices, 18 are declared sterile, 2 reusable, 2 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | M DIALYSIS AB (SE) · FDA 3003733874 |
| Devices in EUDAMED | 24 |
| Country of registration | Sweden |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620178542 | issued | 2028-12-18 |
28620178540 | issued | 2028-12-18 |
28620170242 | issued | 2028-12-18 |