Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014377913

FEI Number

3014377913

Entity Name

RELITECH B.V.

City/State/Country

Nijkerk Gelderland, NL

Establishment Address

van Siburgstraat 34, Nijkerk Gelderland nl-3863 HW, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Relitech B.V. (Owner Number: 10057338)

Owner / Operator Contact Address

van Siburgstraat 34, Nijkerk, NL-GE nl-3863 HW, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ThermaChem HT2000

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	2018-03-23

Official Correspondent

Jack Musters

US Agent Details

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

Related Public Records

Same Entity

Relitech B.V.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3005699784	THERMASOLUTIONS LLC.	White Bear Lake, MN, US
3006986257	ThermaSolutions Europe B.V.	Breda Noord-Brabant, NL
3012706378	STICKMAN DIALYSIS INDUSTRIES INC.	Arundel, ME, US
3003661577	KLUGE DESIGN INC.	Rogers, MN, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014377913. Last updated year: 2026. Please use registration number 3014377913 when referencing this establishment in official correspondence.