Since our establishment in 1966, we have been developing and producing
medical devices using the most advanced electronics technologies. We are
able to accomplish any continuous operation, such as inquiry, planning,
design, trial manufacture, assembly, and manufacturing. Because of the
continuous operation technique, we are able at anytime to apply for authorization
for your convenience, making models of such things as circuit boards (PCB)
or full devices. Of course we are also available for assembling mass production,
but you are always very welcome to ask us to make even just one model.
ISO13485
Medical devices-Quality
management system
£hrn13485
We have tried to acquire ISO13485 positively for merchandise quality improvement and to maintain higher safety. As a result, we were certified in November, 2004 ahead of other Japanese companies in the same industry. By using the ISO standard, we can swiftly and accurately adjust products to the changing needs of customers, improving both our products and customer satisfaction.
¦hrn13485 is a standard quality control and management system for manufacturing
in medical device industries. This standard demands avoidance of all risk
and constant improvement of a company's quality control and management
system.
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‘Authorization and Certificates‘
The Pharmaceutical Affairs Law
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Medical Device Marketing Authorization Holder 42B1X00001
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Medical Device Manufacturing Authorization Holder 42BZ000007
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Medical Device Repair Authorization Holder 42BS200001
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Medical Device Sales Authorization Holder 202NI0008
Electrical appliance and Material Control Law
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Certificate for Manufacture of Alternating Current Electrical Motor-Operated Appliances No.53
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Certificate for Manufacture of Heating Appliances No.45
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Certificate for Manufacture of Electronic Appliances No.52
‘Product Performance‘
Electronic Potential Medical Treatment Device
Low Frequency Medical Treatment Device
Warmer Medical Treatment Device
High Frequency Medical Treatment Device
Moxibustion Medical Treatment Device
Massage Machine and Air Massage Machine
Combined Medical Treatment Device (any two choices among low frequency,
heating, electronic- potential and massaging)
Water Purification Machine
And Many More
We are happy to fulfill any of the following requests for outsourcing:
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about patent, utility model rights, practical new device, trademark rights,
etc.
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making a proposal of new merchandise, design for merchandise etc.
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circuitry, programming, appearance, etc
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making a model of a small part or miniature device; making a model of a
circuit board, specific parts, or the entire design
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application agent for authorization, certificate, or licensing from the
Ministry of Health, Labor and Welfare or any organization in Japan.
Because of amendments to the Pharmaceutical Affairs Law, in addition to authorization for manufacturing and sale practices, marketing practices [a combined authorization of manufacturing and sales] are now possible. Since this change, our company has received all forms of authorization, enabling us to manufacture, sell or both manufacture and sell any merchandise for your convenience. For instance, if you have sales without marketing authorization, but you have a good idea for new merchandise, please ask us for help. We will manufacture excellent merchandise for you. Or, supposing that you have all authorizations, you can still outsource design, manufacture, etc. We look forward to any such request as well as any questions you may have about difficulties or troublesome steps in your production.
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assembly, trial testing,
completion, wrapping (manufacturing medical devices requires
authorization, or we will be happy to outsource.)
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repairing medical devicesiexcept for specific maintenance control medical
divicej
¦repairing medical devices requires authorization