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Medical Device Registration Suppliers & Manufacturers
30 companies found
Premium
based inCarlsbad, CALIFORNIA (USA)
Founded in 1957, the Myron L Company is one of the leading manufacturers of water quality management instruments in the world. Because of our commitment to customer satisfaction and product improvement, you have our assurance that any changes will ...
The DIGITAL DIALYSATE METER is specifically designed to test both acetate and bicarbonate dialysate quality. Measure Conductivity, pH and Temperature to ensure proper mixing during dialysate preparation and as a final check of dialysate quality ...
based inShenzhen, CHINA
Rayto is a leading and professional manufacturer of IVD devices and related software. Main products include Chemistry Analyzer, ELISA Reader and Washer, Coagulation Analyzer, Hematology Analyzer, Chemiluminescence Analyzer and Urine Analyzer. And ...
based inChangsha, CHINA
Sinocare has 20 years experiences in BGM industry since its foundation in 2002, it is the biggest BGM manufacturing facility company in Asia and the first listed blood glucose meter manufacturer company in China, dedicating to the innovation of ...
based inViadana, ITALY
KNOW MEDICAL Srl was founded in 1990. The wide catalogue includes disposable products which regard all the aspects of the medical field. In the beginning it dealt mainly with technical assistance to other companies and registration of medical ...
based inNiegoszowice, POLAND
Laboratoire Lʻideal Parisien Sp. z o.o. has been developing its competences in the field of production of medical devices for years. The implemented Quality Management System for medical devices in accordance with the requirements of ISO 13485 ...
based inDortmund, GERMANY
KombiMED GmbH has been operating in the German market since 2017, catering to customers in Eastern Europe and the Commonwealth of Independent States (CIS). Our clientele includes clinical diagnostics and food laboratories, medical facilities, ...
Approval of medical devices in the Commonwealth of Independent States. Since the approval of medical devices in the Commonwealth of Independent States (CIS) is based on a separate product test, approval procedures for European companies are often a ...
based inSanta Clara, CALIFORNIA (USA)
Proregulations is a leading product safety and regulatory consulting firm with a long-standing core mission of "Value in Compliance". We provide complete regulatory compliance solutions for multiple regions including Asia Pacific, Europe, and ...
U.S. FDA Medical Device Establishment Registration and Listing: DA has divided into two groups of establishments which is domestic and foreign establishments. In general, if you are a manufacturer ...
based inSan Jose,, CALIFORNIA (USA)
RSIP Vision, led by Ron Soferman, is an established leader in computer vision and image processing R&D. In its 25 years of operation, RSIP Vision has provided countless clients with advanced customized software for their core businesses, using ...
Treating head and neck disorders and diseases requires not only advanced imaging techniques, but also innovative and accurate analysis using AI and deep learning tools. RSIP Vision has proven expertise and experience in ENT, ...
based inXi`an, CHINA
Since its establishment in 1997, Tianlong has been committed to the research and development, production and overall solutions of instruments and reagents in field of genetic testing and molecular diagnostics. With its own sustainable development ...
based inHangzhou City, CHINA
Hangzhou Beneware Medical Equipment Co.,Ltd is a high-tech enterprises based on Zhejiang University for the technical and personnel support, specializing in medical equipment industry, set research and development, production, sales and service. Our ...
based inChangsha City, CHINA
As a professional household medical devices manufacturer, it has 29 wholly-owned subsidiaries,2 holding subsidiaries,1 equity holding company, and 426 branches office. It has developed into a group enterprise integrating R&D, manufacturing, sales ...
based inQingdao, CHINA
Established in 1987, Aucma Co., Ltd. has emerged as a significant player in the refrigeration equipment sector, gaining a notable standing since being listed on the Shanghai Stock Exchange in 2000. The company seeks to build enduring relationships ...
based inBeijing, CHINA
Founded in 2012, Biosis Healing is a notable Chinese brand specializing in biological medical solutions. It develops innovative SIS (Small Intestinal Submucosa) biomaterials aimed at tissue repair and regeneration across a spectrum of surgical ...
The Biosis Healing Biological Hernia Graft is designed specifically for hernia repair using a highly specialized porcine small intestinal submucosa material (SIS material). The graft undergoes rigorous processing involving virus inactivation, ...
based inOld Bethpage, NEW YORK (USA)
Himed is a pioneering entity in biomaterial surface treatments and production, boasting a 30-year legacy of innovation since its inception in 1991. Specializing in hydroxyapatite coatings and apatitic abrasives, Himed has made significant ...
based inSan Jose, CALIFORNIA (USA)
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous ...
This pack of 2 courses contains the essentials of FDA Medical Device regulations. In the United States, the US Food and Drug Administrates Medical Devices through several different ...
based inBudapest, HUNGARY
Founded in 1996, 3DHISTECH is the first European manufacturer of digital pathology devices and one of the global market leaders with more than 2000 systems sold. Please browse the list of our reference institutes here. What differentiates us from ...
The CaseManager pathology management system gives the pathologist full control of the clinical workflow. CaseManager offers a comprehensive system from digitization through pathologist assignment, primary inspection, additional orders, and ...
based inAustin, TEXAS (USA)
Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. With a presence on six ...
Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. However, PMS rules can vary between different ...
based inBao`an District, CHINA
AMBULANC (SHENZHEN) TECH. CO., LTD was established in 2001 by emergency care experts. Amoul (Brand name) is dedicated to innovating and developing life support total solutions and manufacturing respiratory therapy, CPR, emergency and critical care ...
based inLund, SWEDEN
We integrate medical audio, video, monitoring, and imaging from any equipment or modality, including X-ray, endoscopy, and ultrasound, in order to simplify high-quality image management for hospitals. With solutions that work with any make, brand, ...
based inFalconara Marittima, ITALY
Endo Engineering is a consulting company specialized in CE certification and product certification. The company offers many professional and qualified services for CE marking, which is necessary to sell products in the European Market, and for ...
The DM 21 December 2009 establishes the obligation to register in the medical devices database uses new methods. Registration is mandatory for all manufacturers and other entities responsible for ...