Refine by
Medical Device Registration Suppliers & Manufacturers
26 companies found
based inKraków, POLAND
Instytut Biotechnologii Surowic i Szczepionek BIOMED Spółka Akcyjna is a Polish biotechnological company combining modernity with tradition. We manufacture biological medications (biologicals), in particular specific and non-specific bacterial ...
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 ...
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 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 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 inJinan, CHINA
Founded in 2003, Jinan Babio Biotechnology Co., Ltd. is a professional high-tech enterprise which concentrates on the R&D, manufacturing and selling of in vitro diagnostic reagent. The company was successfully listed on the NEEQ (National Equities ...
based inLublin, POLAND
We are a Polish biotechnology company with long manufacturing traditions. We have been present on the Polish and international markets since 1944. We are challenged and truly honoured to provide the leading, innovative medical solutions, and, due to ...
Name of the Medicinal Product: GAMMA anty-HBs 200, 200 IU/ml solution for injection. Qualitative And Quantitative Composition: Human hepatitis B immunoglobulin. 1 ml of the solution contains human protein not less than 100 mg, of which at least 85% ...
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 inPlano, TENNESSEE (USA)
Integer is a leader in advanced medical device outsourcing. Our story is one filled with 80 years of industry-changing innovations and exemplary manufacturing. It’s a legacy we are proud of as we continue to provide customers with unparalleled ...
We provide a full range of solutions to support every phase of the product life cycle of diagnostic mapping catheters. Design and development of complex diagnostic mapping catheters including diagnostic EP catheters, high-density mapping catheters ...
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 inShanghai, CHINA
Innovative Material and Devices, Inc. (IMD), is a Sino-American Joint Venture Company founded in 2004 who engaged in R&D, manufacturing and marketing of dental products and personnel protective equipment (PPE). IMD is one of the industry-leading ...
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 inJIANGXI, CHINA
CAROLADO CO., LTD was established in 2014 with a registered capital of 5 million yuan. The company is committed to the production and sales of self-developed medical molecular sieve oxygen generators, small hospital oxygen generation systems, and ...
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 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 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 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 inWashington, DISTRICT OF COLUMBIA (USA)
Bergeson & Campbell, P.C. is an AV-rated (highest ranking) Washington, D.C. law firm focusing on conventional and nanoscale, industrial, agricultural, and specialty chemical product regulation and approval matters, including TSCA matters, FIFRA/FQPA ...
based inHangzhou, CHINA
Chemical Inspection and Regulation Service (CIRS) is a leading product safety and chemical management consulting firm providing valued product regulatory compliance service, tailored solutions and original information to help our clients gain ...
Medical Devices and In Vitro Diagnostics Product Regulatory Compliance in China. Pre-market Investigation & Analysis. Medical Devices Registration & ...
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 ...