Who We Are
Shenyang Shengshi Medical Technology Co., Ltd (SSMT) is committed to R&D and the manufacture of medical devices as well as the introduction and transmission of medical technologies. SSMT upholds People-Foremost and Market-oriented strategy and makes remarkable achievements in medical device development and manufacture.
SSMT was founded in 2014 with an initial registered capital of $3.5 million. Our factory is located in No. 12-3(1st Floor) & No. 12-2 (2nd Floor), Kunminghu Street, Economic and Technological Development Zone, Shenyang, Liaoning Province, China. SSMT’s factory covers a land of 10,000㎡, including a 6000㎡ D-Grade purification workshop. By virtue of advanced production and test equipment imported from overseas and excellent quality management systems, the safety and effectiveness of SSMT’s products are guaranteed. SSMT strives to manufacture premium medical devices and insist on a standardized development strategy in the competitive market. SSMT is devoted to being a leading medical device manufacturer both at home and abroad.
SSMT started to manufacture medical protective masks ever since 2014 and gained a rich and mature production experience. In late January 2020, in response to the national call-up, SSMT recovered production of masks. At that time, the daily production capacity of medical protective masks across China is 160,000pcs, and that of SSMT is 20,000pcs, the only manufacturer reached such capacity in Liaoning Province. To fight against COVID-19, our masks were delivered to healthcare authorities for general distribution. Due to its efforts and contribution to the Anti-COVID19 campaign in Wuhan, Beijing, and Liaoning, SSMT won praises and attention from leaders of Liaoning Province and Shengyang City. SSMT is among the 1st batch of Key Medical Device Production Entities and expands production capacity in response to the national and local Anti-COVID19 campaigns. Till now, SSMT has finished its new purification workshop (6000㎡, D-Grade), established 32 production lines for medical protective respirators and surgical face masks, and expanded mask production capacity to 2,000,000pcs per day. In April 2020, SSMT gets ISO13485 Quality Management System Certificate (QMS for medical devices), which is the evidence showing that we have made significant improvements in both management and product quality. ISO13485 QMS helps us ensure the safety and effectiveness of our products; it also encourages us to manufacture conforming products continuously.
What We Do
SSMT is mainly engaged in the production of medical protection equipment and devices, including medical protective respirators (non-sterile), medical protective respirators (sterile), personal protective masks (particle filtering respiratory mask), surgical face masks and the like. SSMT got Production Permit and Medical Devices Registration from CFDA (China Food & Drug Administration). SSMT have been established an excellent management system and gained rich experience in pandemic prevention equipment production.
SHE001 Protective Masks, one of the flagship products of SSMT, were tested by Nelson Labs that under the procedure was performed to evaluate particulate filter penetration as specified in 42 CFR Part 84 and TEB-APR-STP-0059, and the procedure was performed to evaluate the differential pressure of non-powered air-purifying particulate respirators in accordance with 42 CFR Part 84.180, the air exchange differential or breathability of respirators was measured for inhalation resistance using NIOSH procedure TEB-APR-STP-0007, and exhalation resistance with NIOSH procedure TEB-APR-STP-0003. The reports indicated that all test method acceptance criteria were met. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210,211 and 820. (Nelson Labs Study Number 1284811-S01, 1284806-S01.2 Amended).
Certification & Qualification
SSMT execute high standards in production and pass all necessary certificates, such as GB2626 accredited by CNAS, GB19083, CE (medical protective respirator, non-sterile), and Deutschland EUA. Meanwhile, our products pass the EU to reach Accreditation, EN149 test, and SSMT had acquired CE for PPE products. In addition, our pandemic prevention products pass ISO10993 and GB16886 tests (no cytotoxicity, no skin irritation, no skin sensitization, stable biological safety).
Since its foundation, SSMT insists on Realistic & Pragmatic, Professional & Dedicated quality policy and execute whole process quality control to provide customers with highly valuable products and make a contribution to the healthcare of human beings by virtue of its professional R&D and manufacture strength.