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【 ISO13485 】
Developing and Manufacturing Electronic and Medical Devices
Contact Person: Leonardo Ryou IGARASHI (Director, Sales Department)
E-mail: [email protected] Tel:+81-48-268-9811 Fax:+81-48-269-0845
Business outline
・Developing and manufacturing electronic and medical devices.
・Sales of measuring instruments.
・Providing technical support and maintenance of imported machines and
devices from overseas.
・EMC noise technical supports.
Strength / Specialty
Our main business is the development and manufacture of medical and
electronic devices. We have developed and manufactured many OEM products.
We are proud our technology produces valuable devices that save human life.
Our manufacturing factory is fully certified to ISO 13485:2003, a
comprehensive standard of quality management systems(QMS), specifically for
Medical Device Manufacturers.
In addition to manufacturing and testing processes, we apply the system to
daily processes such as staff training and corrective actions.
Result of Developments: Radiofrequency ablation system , Atrial
Cardioversion System, Potential difference medical device for home use,
Control device of x-ray photography board, Ultrasonographic fat measuring
device, Impedance fat measuring device, Supersonic measuring device,
Ultrasonographic image processing system, High and low frequency medical
device, Roller massaging machine
事業内容・取扱品目・サービス
・電子機器の開発、製造、販売
・医療電子機器の製造販売、開発、製造
・ファームウェア開発、PCアプリケーション開発
・EMCノイズ対策技術サポート、輸入機器技術サポート
特徴や技術の独自性・セールスポイント
開発実績：心筋焼灼術用治療器（RFアブレーションシステム）、心腔内除細
動装置、家庭用電位治療器、X線撮影台制御装置、超音波皮脂厚・体脂肪計、
インピーダンス方式体脂肪計、超音波音速測定装置、超音波画像解析装置、
低周波・中周波治療器、ローラーマッサージ治療器、動物用人工呼吸器、加
速度記録計など
・ISO13485:2003認証取得
・第二種医療機器製造販売業許可（11B2X10026)
・医療機器製造業（一般）許可（11BZ200125)
Tri-axial motion logger SOROCABA-1
1
Corporate Profile
Representative
Mitsuo IGARASHI (President)
URL
www.cme.co.jp/
Address
2-13-23 Shiba, Kawaguchi city,
Saitama, 333-0866, JAPAN
Tel +81-(0) 48-268-9811
Fax +81-(0) 48-269-0845
Year established 1986
10 Million Yen
Capital
Employee
11
Overseas branches
None
Current overseas business Condition
None
Prospect for overseas business
• Expand market (USA, Korea)
• Find business partner
• Export own products & technology
• Import products & technology
(USA, EU, Korea)
Language
English, Korean