ISO
We have acquired ISO 13485: 2016 quality management system for medical equipment.
ISO13485:2016
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Certification standard | ISO13485:2016 |
| Sites of certification | Head Office and L&E Center | |
| Scope of certification | 1. Manufacture and sales of electrocardiogram electrodes 2. Sales of non-sterile surface electromyography electrodes, non-sterile pulse oximeter probes, sterile electromyography needle electrodes, sterile electroencephalography needle electrodes 3. Sales and service of fresh frozen plasma thawing devices |
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| Initially Issued | 27march 2008 | |
| Certification number | JP08/040065 | |
| Certification Authority | SGS Japan Inc. |