For Those Who Are Interested in OEM/ODM

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Offering Our Unique Silicone Processing Technology to More Companies

Over the years, Fuji Systems has been working on the development and production of a wide variety of medical devices using silicone. With our expertise that we have developed, we offer OEM/ODM services to numerous medical device manufacturers. We can submit an application for marketing approval for medical devices of up to Class IV (specially controlled medical devices). We make a wide range of suggestions to meet your demand.

Characteristics of OEM/ODM of Fuji Systems Corporation

  • OEM/ODM supply of medical devices and medical device parts, including catheters made mainly of silicone
  • Manufacturing at our ISO 13485-certified domestic plant
  • Product development using unique technology
  • Acquired Medical Device Manufacturing Industry Registration/First Class Medical Devices Marketing License
  • Provision of technology and commercialization of general medical devices as well as specially controlled medical devices

Strengths of OEM/ODM of Fuji Systems Corporation

Manufacturing environment

  • ・A wide variety of molding methods, including extruders, pressing machines, injection molding machines, LIM molding machines, and dip molding machines, allow for optimal manufacturing for each product
  • ・EOG sterilization at our domestic plant

Acquisition and registration of licenses

  • ・Acquired Medical Device Manufacturing Industry Registration/First Class Medical Devices Marketing License
  • ・We can supply parts in addition to pharmaceutical-approved products

Our unique expertise

  • ・Gas barrier silicone balloon to prevent the loss of air and water
  • ・Catheters with silver-based antimicrobial agent

Quality Control

  • ・Manufacturing in our ISO 13485-certified environment
  • ・Integrated process of cleaning, assembly, processing, and packaging in clean rooms (Class 100,000)

Flow of contract manufacturing



After you make an inquiry, one of our representatives will contact you shortly.


Determination of specifications

We determine the quality and functionality of the product based on your request.


Design and development

We design a specific manufacturing method by taking into account the product characteristics.


Prototyping and evaluation/pharmaceutical application

We create prototypes and check to ensure that they satisfy your standards. We also submit a pharmaceutical application as needed.


Mass production

After obtaining an approval for commercialization based on the prototype, we start mass production of the product under strict quality control.


Packing and shipment

We pack and ship the product after inspection.

Product examples

  • ・Molded silicone products
  • ・Silicone tubes
  • ・Silicone catheters with antimicrobial agent
  • ・Silicone catheters with hydrophilic coating
  • ・Sterile surgical microscope drapes
  • ・Trocar sleeves for laparoscopy
  • ・Gastrostomy feeding tubes for short term use
  • ・Urinary Foley catheters for short term use
  • ・Peritoneal dialysis catheters
  • ・Intravascular catheters
  • ・Over tubes
  • ・Silicone hollow fiber

If you are interested in OEM/ODM, please feel free to contact us.