Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006986257

FEI Number

3006986257

Entity Name

ThermaSolutions Europe B.V.

City/State/Country

Breda Noord-Brabant, NL

Establishment Address

Takkebijsters 41, Breda Noord-Brabant 4817, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

THERMASOLUTIONS LLC. (Owner Number: 9082263)

Owner / Operator Contact Address

1889 Buerkle Road, White Bear Lake, MN 55110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ThermoChem HT-2000 ThermoChem HT-2500 ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) FLW-0111 Long Lasso Tubing PAK-0112 Inflow and Outflow Tubing Pack FLW-0010 Lasso Tubing FLW-0120 Inflow Tubing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MLW	Warmer, Peritoneal Dialysate	Gastroenterology, Urology	Class 2	876.5630	2013-10-28
MLW	Warmer, Peritoneal Dialysate	Gastroenterology, Urology	Class 2	876.5630	2025-11-24
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2022-12-27

Official Correspondent

Rhea Johny

US Agent Details

Gregg Giza Business: THERMASOLUTIONS, LLC Email: ggiza@thermasolutions.com Phone: (651) 2093900

Related Public Records

Same Entity

THERMASOLUTIONS LLC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005699784	THERMASOLUTIONS LLC.	White Bear Lake, MN, US

Similar Registrations

Registration Number	Establishment Name	Location
3014377913	RELITECH B.V.	Nijkerk Gelderland, NL
3005699784	THERMASOLUTIONS LLC.	White Bear Lake, MN, US
3012706378	STICKMAN DIALYSIS INDUSTRIES INC.	Arundel, ME, US
3003661577	KLUGE DESIGN INC.	Rogers, MN, US
3032912826	KMD SURGICAL SOLUTIONS, INC.	Winston Salem, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006986257. Last updated year: 2026. Please use registration number 3006986257 when referencing this establishment in official correspondence.