Data / Medical devices / Netherlands / ThermaSolutions Europe B.V.
ThermaSolutions Europe B.V.: FDA-registered device maker in Breda Noord-Brabant, Netherlands, 3 510(k) clearances
ThermaSolutions Europe B.V. is registered with the FDA (registration 3006986257) in Breda Noord-Brabant, Netherlands. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 5, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006986257
- Address
- Takkebijsters 41, Breda Noord-Brabant, Netherlands, 4817
- Owner or operator
- THERMASOLUTIONS LLC. (9082263)
- Roles
- Exporter to the US
- First device listed
- April 6, 2006
- Registered through
- 2026
- Brand names listed
- FLW-0010 Lasso Tubing, FLW-0111 Long Lasso Tubing, FLW-0120 Inflow Tubing, PAK-0112 Inflow and Outflow Tubing Pack, THERMOCHEM HT-1000, ThermoChem HT-2000, ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000), ThermoChem HT-2500
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Exporter to the US | accessdata.fda.gov |
| Warmer, Peritoneal Dialysate | MLW | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 5, 2025 | K240447 | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | MLW | Unknown | Thermasolutions, LLC | accessdata.fda.gov |
| October 3, 2013 | K131583 | THERMOCHEM HT-2000 | MLW | Substantially Equivalent | Thermasolutions, Inc. | accessdata.fda.gov |
| December 30, 1999 | K993330 | THERMOCHEM-HT SYSTEM | MLW | Substantially Equivalent | Hemocleanse, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.