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Why Can We Always Ensure Excellent Quality

Quality Control

Umitai Medical Technology company have a management team with a auccessful track record.We are implementing and maintaining the highest industry standards throughout design, development and manufacturing. Our products are manufactured according to the ISO11608-1 standard.All our processes are subject to the medical device guidelines and are certified according to ISO 13485:2003. For Umitai, compliance with this standard means not only implementing a quality system but also ensuring that quality-oriented thinking is a core component of our corporate philosophy.We ensure the lowest possible level of risk through a systematic approach comprising all steps and aspects of device handling, design and manufacturing.For the commercial demand of our customers we manufacture every year hundreds of millions of parts, components, subassemblies and finished products that pose many challenges for quality management. Our quality systems are systematically challenged during numerous audits every year by customers and regulatory authorities. The CFDA on-site audits performed in December 2015, March 2017 did not generate any unqualified items .

Shanghai Umitai Medical Technology Co.,Ltd

Certification

Shanghai Umitai Medical Technology Co.,Ltd Certifications
Standard: Class II registration certificate
Number: 沪械注准20162150497
Issue Date: 2016-07-24
Expiry Date: 2021-07-23
Scope/Range: Subcutaneous injection
Issued By: CFDA
Shanghai Umitai Medical Technology Co.,Ltd Certifications
Standard: production certificate
Number: 沪食药监械生产许20172403号
Issue Date: 2017-03-28
Expiry Date: 2022-03-27
Scope/Range: class II 6815
Issued By: CFDA
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