PulseLavage AB
SE-MF-000002363 · Sweden · Knivsta
PulseLavage AB is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|---|
| Class I | 1 |
Most frequent device types declared: MCS-20, GreenPulse, GP4, Without Teeth , With Teeth.
Among these devices, 6 are declared sterile.
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 | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| Country of registration | Sweden |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
M.2023.MDR.1013 | cancelled | 2027-04-05 |
M.2023.1014 | cancelled | 2028-04-05 |