FDA Registered Products

FDA registered products

TOYOSILICONE Hose Series products (hoses, assemblies, integrally molded couplings) are registered in the Drug Master File (DMF) Type II as of January 2012.TOYOFUSSO Hose Series products (hoses, assemblies) are registered in the Drug Master File (DMF) Type II as of May 2018.
The registration number is 25486.
*However, safety is not guaranteed in its entirety.
*It is necessary for customers to judge the particular safety conditions of their respective workplaces beforehand. (Precautionary reference material)

A list of registered companies’ DMF files is available on the FDA’s official site here>>>
(The number on the left, “25486,” is the listing for the TOYOSILICONE Hose and TOYOFUSSO Hose Series products)

FDA registered

TOYOSILICONE Hose, Hose Assemblies, and TOYOSEAL hose edge face treatment
HYBRID TOYOSILICONE Hose and Hose Assemblies
TOYOSILICONE S Hose and Hose Assemblies
TOYOSILICONE-S2 and Hose Assemblies
TOYOSILICONE-P Hose and Hose Assemblies
TOYOSILICONE FERRULE Hose (Integrally molded ferrule coupling)
TOYOFUSSO Hose and Hose Assemblies
TOYOFUSSO-E Hose and Hose Assemblies
TOYOFUSSO-S Hose and Hose Assemblies
TOYOFUSSO SOFT Hose and Hose Assemblies

As proof of FDA certification, Toyox hose and coupling products bear the below markings:

display the FDA marking as a sign of trust

*DMF register number markings are on products made from April 2012, however, products manufactured before that time that do not have the marking are also treated as registered products.

About the FDA

  • The FDA, the U.S. Food and Drug Administration, is similar to the Japanese Ministry of Health, Labor and Welfare, and is one part of the HHS(Department of Health and Human Services). It is an abbreviation for Food and Drug Administration.
  • The purpose of the FDA is to provide market approval, carry out inspections both before and after distribution, and review the safety and efficacy of medicine and food related products in order to ensure the safety of American citizens.

FDA examination standards are very strict and known as proof of a products safety and reliability.

Notes for use

TOYOSILICONE Hose Series products (Hoses, assemblies and integrally molded couplings), and TOYOFUSSO Hose Series products (hoses and assemblies), are developed and produced for general industry applications.

For applications that require safety, confirm in advance.

Never use for implant or injection application or other applications where there is a possibility of the product partially remaining in the body.
Toyox makes no guarantee of the adaptability or safeness related to such applications.

We provide a wide range of support from selecting ideal products for specific usage conditions to downloading certificates regarding laws and regulations, as well as downloading of materials such as catalogs.

You can download useful materials that address issues such as “leaks and disconnections”, “energy-saving measures”, and “odor and coloration.”

We use videos to introduce the benefits of using products and how to install them, which may be difficult to understand just using text and illustrations.

We have compiled frequently asked questions from customers in the “FAQ” section.

To assist you in making selections, we provide common examples of improvements for hoses and couplings through industry-based case studies.