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Mersa International Certifications
CE Credentials
The Plasma Firebolt device , manufactured by Mersateb Tajhiz medical device company, holds
the EU standard of CE2195. The CE standard has been developed by the European committee
for standardization (CEN). Only products with CE marking, i.e. products compatible with specific
standards and specifications, are permitted to be launched in the European Union’s markets.
The standard has the highest level of strictness in medical device industry so that the highest
quality products can be launched in the market.
ISO 13485:2016
ISO 13485 is a specialized certificate of quality management standard in medical device
industry. Mersateb Tajhiz standard has been issued by South Korea’s USCert; it guarantees that
the company’s products, in all stages, from design to production, quality control, training,
selling, after-sales services, customer complaints handling and other standard services are
compatible with international principles and all these steps are fully supervised.
ISO 9001:2015
The ISO 9001 quality management certificate, which has been issued by Korea’s USCert,
guarantees that all organizational key principles including improving customer satisfaction,
improving fully integrated processes, using evidence-based decision making and creating the
organization behavior of continuous improvement are properly followed, implemented and
observed in Mersateb Tajhiz.
Production License
According to provided license by the national medical device directorate, Mersa Teb Co. has independently started to manufacture the product through the national medical device directorate supervision; besides the use of the company’s manufactured device is as authorized.
We believe that we should always go beyond the standards in medical equipment field; customer’s satisfaction and active support are two features that are beyond standards and credentials.
Number of successful installation of Mersa equipment
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