Hangzhou Singclean Medical Products Co., Ltd.

Website: https://www.singclean.net/

Company Profile

Company Name Hangzhou Singclean Medical Products Co., Ltd.
Location Hangzhou, Zhejiang
Year Founded 2003
Staff 536
Product industries Manufacturer/Factory & Trading Company
Main Products / Services Dermal Filler; Joint Lubrication for Knee; Cross-Linked Sodium Hyaluronate Gels; Fsh Rapid ...

About

Overview of the CompanyHangzhou Singclean Medical Products Co., Ltd. is a high-tech firm in China that integrates research and development, production, and sales of medicinal biomaterials. It was founded in March 2002 and has a registered capital of 80,000,000 RMB.The company guarantees the continuous production of Class III medical devices and drug injection products that comply with the laws and regulations of the EU MDR and the National Medical Products Administration (NMPA) by virtue of its highly qualified staff, comprehensive quality management system, and first-rate facilities.CollaborationIn addition to having well-established R&D cooperation relations with Zhejiang University, Donghua University, and Zhejiang University of Technology, the company established a joint research center with Zhejiang University of Science and Technology. It has developed four series of new products with proprietary intellectual property rights in addition to a variety of high-tech products that will be developed cooperatively.Along with developing an R&D platform for medical biomaterials that is competitive on a global scale, the company has achieved significant advancements in several critical technologies, including anti-adhesion, bleeding control, and basic materials for tissue engineering. To date, the company has obtained over 55 patents and numerous products have applied for additional patents.Our productionThe company's Xiasha factory has a construction area of 174014.83 m², a producing tract of 13, 200 m², and 2, 300 m² of cleanroom space.This has a 2,000 square meter Class C cleanroom and a 300 square meter Class B cleanroom.more than 60 m³, of which Class A is followed.This plant established a new cleanroom that complies with GMP standards, and in 2012, a Pharmaceutical Production License was acquired.It will produce 10 million medical sets and various types of medical equipment with a manufacturing value of $2 billion. Additionally, the plant has added additional production facilities, including a sterilizer from GETINGE, a 5 T/h purified water machine, a 3 T/h water for injection machine, a 1 T/h pure steam generator, and an Invoa filling machine from Germany.High-quality frameworkreverence for life and stringent quality assuranceIn order to maintain the continued suitability and effectiveness of the quality management system, the company has established a documentation-based GB/T19001-2008, YY/T0287-2003, Good Manufacturing Practice for Medical Devices, Good Manufacturing Practice for In Vitro Diagnostic Reagents, Good Manufacturing Practice of Drug, 2010, Medical Device Directive (MDD93/42/EEC). This is done in accordance with quality objectives, audit results, data analysis, corrective and preventive actions, and management review.Innovation in TechnologyCoherence of technical power enhancing fundamental competitivenessThe company has always placed a strong emphasis on product research and development, allocating 10% of yearly revenues into the building of an R&D center, the creation of new products, and the introduction of cutting-edge machinery.The R&D facility features several patent technologies and a cleanroom that is more than 200 m² and classified as Class 10000 (including Class 100).Product divisionThe company is dedicated to creating innovative composite and smart biomaterials. It specializes in the production of biodegradable bio-materials and their derivatives, and currently produces eight series of products: chitosan, medical sodium hyaluronate gels, cross-linked hyaluronic acid sodium gels, microporous polysaccharide, oxidized regenerated cellulose, basic materials of tissue engineering, and in vitro diagnostic reagents. Fifty different types of cosmetics are exported to over 120 countries worldwide, including Australia, Canada, Russia, Turkey, France, Brazil, Chile, Italy, and more.At present, Singclean possesses almost thirty CE certificates, sixteen certificates for medical device registration, and forty-six patent certificates.All 600 of Singclean's staff are dedicated to excellence and work with the best.