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 ...
With the ever-increasing stringency, time, and expense associated with FDA approval for medical devices, debate is sharpening in the medical devices industry over whether it is actually better ...
SAN DIEGO--(BUSINESS WIRE)--Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, ...
SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of patient-centric clinical-grade blood collection solutions, today announced it received CE Mark certification for its Tasso+™ device, a ...
Roche’s Elecsys pTau181 test has secured CE Mark approval, marking a development in ruling out Alzheimer's disease. The minimally invasive blood test measures phosphorylated Tau (pTau) 181 protein, a ...
Memphasys Ltd ( ($AU:MEM) ) has provided an update. Memphasys has secured CE Mark approval under the European Union Medical Device Regulation for ...
Medical Device Network on MSN
Shape Memory Medical’s embolisation plugs gain CE mark under EU MDR
Shape’s CE mark under the EU MDR encompasses its Impede and Impede-FX embolisation plugs and Impede RapidFill delivery ...
Only a month after Getinge announced the suspension of the CE marks allowing it to sell its heart-lung support and permanent life support systems in Europe, the Swedish devicemaker has temporarily ...
DUBLIN, Ireland, May 20, 2022 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB) has achieved a CE Mark for its 10-minute Covid-19 antigen test. This CE mark allows for use by healthcare ...
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