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 IIb | 2 |
|---|---|
| Class IIa | 3 |
Most frequent device types declared: HT-2000, PDT-5500, TSP1016, TSP1019.0, TSP2011.
Among these devices, 4 are declared sterile, 1 reusable, 5 active, 4 with a measuring function.
Devices declared under this manufacturer
- HurriChem
- Hyperthermic Perfusion Kit
- ThermoChem HT-2000
Catalogue references include 101-2000, PDT-5500, TSP1016, TSP1019.0, TSP2011.
European nomenclature codes declared: Z12040219, Z12159002, Z1204021501.
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; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 20.0 % |
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | THERMASOLUTIONS LLC |
⚠️ A similar name exists; unverified — why.
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2025-06-17 |
Licence types: Device Group (1).
Licensed under: HURRICHEM DEVICE KIT DEVICE.