ThermaSolutions Europe BV
NL-MF-000022782 · Netherlands · Breda
ThermaSolutions Europe BV is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 3 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: PDT-5500, TSP1016, HT-2000, TSP1019.0, TSP2011.
Among these devices, 4 are declared sterile, 1 reusable, 5 active, 4 with a measuring function.
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 | Similar name found — unverified |
|---|---|
| Matched entry | ThermaSolutions Europe B.V. (NL) · FDA 3006986257 |
| Devices in EUDAMED | 5 |
| Country of registration | Netherlands |
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.