Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011853381

FEI Number

3011853381

Entity Name

HILOTHERM GMBH

City/State/Country

Argenbuhl-Eisenharz Baden-Wurttemberg, DE

Establishment Address

Wittumweg 38, Argenbuhl-Eisenharz Baden-Wurttemberg D88260, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hilotherm GmbH (Owner Number: 10081865)

Owner / Operator Contact Address

Wittumweg 38, Argenbuhl-Eisenharz, DE-BW D88260, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

40000613 Buttons HILOTHERM Homecare 40000357 Transport Trolley Hilocase HTP1 Pro 40000390 Hilofix 25 40000412 Trolley Hiloroll 2-Layer 40000259 Duo Hose 2m 40000422 Head fixing bandage Hilohead 40000612 Service Kit Homecare 40000599 Hilofix 25/65 40000241 Chemo Glove 40000505 Carry Bag 40000236 Hose Isolation 2m 40000250 Hose holder for trolley Hiloroll HT02 2000238 Isolation for Hand Cuff 40000322 Grating 40000251 Hilofix 75 HILOTHERM Professionell 40000240 Chemo Footsie 40000413 Trolley Hiloroll 3-Layer HILOTHERM ChemoCare 20000239 Isolation for Foot Cuff 40000310 Filter 40000423 Hilocap ChemoCare 40000600 Service Kit Clinic HILOTHERM Clinic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2021-05-21

Official Correspondent

Christian Stegmann

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Hilotherm GmbH

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3011684767	NICE RECOVERY SYSTEMS LLC	Boulder, CO, US
3016171827	SHENZHEN SHUICHANG TECHNOLOGY CO., LTD	Shenzhen City Guangdong, CN
3015004731	ADVANCED AMBULATORY, INC	Houston, TX, US
3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3010675856	KINETEC USA	Jackson, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011853381. Last updated year: 2026. Please use registration number 3011853381 when referencing this establishment in official correspondence.