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 |
|---|
Most frequent device types declared: Intravenous Microdialysis Catheter, Linear Microdialysis Catheter, Microdialysis Catheter, Microdialysis Pump, Perfusion Fluid.
Among these devices, 18 are declared sterile, 2 reusable, 2 active.
Catalogue references include 8003295, 8010191, 8010343, 8010651, 8010670, P000055.
European nomenclature codes declared: F05, V0999, A010199, Z12030302, W050180, W02010199.
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 |
Device-level evidence
| Devices with a numeric GTIN | 24 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 20.8 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. M Dialysis AB is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620178542 | issued | 2028-12-18 |
28620178540 | issued | 2028-12-18 |
28620170242 | issued | 2028-12-18 |