European rules for obtaining CE marking on products sold to EU Member States or in the EEA - conditions and product requirements for the conformity marking ...
SAN CARLOS, Calif.--(BUSINESS WIRE)--The first diagnostic designed to identify patients with long COVID has received CE-IVD marking in Europe. It is ready for its formal launch in countries accepting ...
ReShape Lifesciences Implants First Patient in ENDURE II Trial to Support CE Marking of ReShape Vest
SAN CLEMENTE, CA / ACCESSWIRE / April 1, 2019 / ReShape Lifesciences Inc. (RSLS), a developer of minimally invasive medical devices to treat obesity and metabolic diseases, announced today that the ...
Many manufacturers and suppliers of electronic military equipment are confused about CE marking requirements, with many presuming their products are exempt from normal commercial regulations. However, ...
Under the EU MDR, manufacturers must prepare and submit a comprehensive Technical Documentation File for devices that require CE marking. The Clinical Evaluation Report (CER) is a crucial component of ...
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Mindray is the first and only Chinese medical device company to have passed the assessment of the European Directive 98/79/EC (IVDD) for List A tests. SHENZHEN, China, Oct. 24, 2017 /PRNewswire/ -- ...
Manufactured steel is one of the few materials that can move from design intent to site reality with very little ...
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