Technical
Manufacture of Parts for Medical & Healthcare Use

Technical

Manufacture of Parts for Medical & Healthcare Use

Manufacture of products for medical, dental and extracorporeal examination

・Cleanroom environment (class 100K) enables us to provide high-cleanliness products.
・Filling process is operated in cleanroom (class 100). It is capable of coherent production from liquid preparation, filling, fabricating to packaging.
・To offer a feeling of trust and security to a customer in providing parts for medical and dental use, we got certified with ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes) in February 2010.

Cleanroom in Tsukuba Plant

Electric injection molding machine(Clean room class 100,000)

  • Manufacturing equipment

    1. 75 Ton(2)
    2. 100 Ton(3)
    3. 130 Ton(1)
    4. 160 Ton(1)
    5. 60 Ton(1)
    6. 160 Ton(1)

Assembly(Clean room class 100,000)

  • ·Various operations (ultrasonic welding, heat sealing, etc.) possible

    ·It is also possible to produce equipment required for production, such as fully automatic assembly equipment and 100% inspection equipment.

Filling(Clean room class100~1000)

  • ·We have liquid preparation, autoclave and filling equipment

    ·Aseptic filling is possible

    ·Implementation of antibacterial control

ISO 13485 Certification, Registration as a Medical Device Manufacturer

Certificate

  • Medical Device Manufacturing Industry Registration Form

  • Medical device management (ISO13485)

  •