Sabun Industrial’s medical enterprise is primarily devoted to the manufacture and sale of medical instruments for orthopedic surgery (Class III Medical Devices).
Sabun Industrial has a long history of superior craftsmanship. As a manufacturer, we are committed to contributing to medical care and healthcare by utilizing our deep knowledge and experience to develop safe and efficient surgical instruments designed to reduce the burden of both patients and medical practitioners.
Product Manufacturing Process
To understand clinical practitioners’ needs and save clients time during the product development phase, we provide assistance for the design and development of medical devices right from the implant design stage.
- To understand clinical practitioners’ needs, we start with face-to-face meetings. We’ll travel anywhere in the country to meet in person.
- 02Design and Development
- We design devices to match your specific needs. If technological difficulties are involved, we can suggest solutions from an engineering standpoint.
- 03Prototyping and Testing
- We conduct preclinical testing for factors such as performance, durability, and sterilization resistance.
- We oversee the manufacture of each and every part in-house. We use state of the art facilities and processing technology to ensure consistent quality.
- 05Quality Assurance
- We conduct thorough quality assurance in accordance with ISO13485 and the Japan Pharmaceuticals & Medical Devices Law to ensure superior standards of product quality and safety.
- 06Registration for Manufacture and Sale
- Per request, we are happy to conduct the necessary registration process for manufacture and sale.
- 07After-Sales Support
- Our in-house manufacturing process allows us to respond promptly to problems and repairs. Our sincere support service is one more reason that customers can feel confident choosing Sabun Industrial.
Certifications and Licenses
- ISO 13485(Head office Factory, Kitsu Factory medical equipment department.)
- Class III Medical Device MAH License: 15B3X00017
- Medical Device Manufacturer Registration: 15BZ200014
- Medical Device Manufacturer Registration: 15BZ006015 (Kitsu Factory)
- Silicone Grips
- Available in different shapes & formats
- Custom Order Option Available
- Biocompatibility Tested
- ■Torque Handles
- Clutch release feature for preventing over-torque
- Torque Value: 0.1Nm - 12Nm
- Compact design
- Maximum Load: 5Nm
- Steel Surgical Instruments
- Utilizing our deep knowledge of metalworking, we provide a wide range of services, including product development support, special order manufacturing, and mass production.