ThermaSolutions Europe B.V.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006986257 | 3006986257 | ThermaSolutions Europe B.V. | 1 | N | 2026-01-01 | Takkebijsters 41 Breda Noord-Brabant NL 4817 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 220150 | 1900037050 | K993330 | THERMOCHEM-HT SYSTEM | MLW | 1999-12-30 |
| 220150 | 1466348027 | K240447 | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | MLW | 2025-05-05 |
| 220150 | 1284381970 | K131583 | THERMOCHEM HT-2000 | MLW | 2013-10-03 |
| 220150 | 1650881127 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MLW | 3 | 2025-05-05 |