Shares of ReShape Lifesciences Inc. (RSLS) jumped over 33% on Tuesday morning after the company said its entire European and United Kingdom product portfolio has received Medical Device Regulation Certification.
RSLS is currently trading at $5.75, up $1.44 or 33.41%, on a large volume of 17.5 million, above average volume of 0.7 million, on the Nasdaq. The stock opened its trading at $5.70 after closing Monday at $4.31. The stock has traded between $4.03 and $414.70 in the past 52-week period.
ReShape Lifesciences announced that its Quality Management System (QMS) and entire commercial portfolio of medical devices sold in Europe and in the United Kingdom (UK) have been certified under the European Union (EU) Medical Device Regulation (MDR) (EU) 2017/745 and UK Conformity Assessment (UKCA), respectively.
The EU MDR, which replaced the Medical Device Directive (MDD) in May 2021, sets significantly more stringent requirements for clinical evaluation, post-market surveillance, and device traceability.
"Achieving MDR and UKCA certification well in advance of the December 31, 2027 regulatory deadline is a significant milestone that firmly establishes ReShape Lifesciences among a select group of medical device manufacturers capable of meeting the European Union's rigorous new standards," stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences.
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