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: GP4, GreenPulse, MCS-20, With Teeth, Without Teeth.
Among these devices, 6 are declared sterile.
Devices declared under this manufacturer
- GreenPulse
- GreenPulse Hip Set
- OrthoLavage
- RetraLight
Catalogue references include GP4000, MCS-20, OL2000B, RL4000, RL4001.
European nomenclature codes declared: A03010201, K01020106, K01020101, V901699.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. PulseLavage AB was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
M.2023.MDR.1013 | cancelled | 2027-04-05 |
M.2023.1014 | cancelled | 2028-04-05 |