$RMED's Electrophysiology Division Submits Data fo
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Posted On: 06/28/2023 9:30:30 AM
$RMED's Electrophysiology Division Submits Data for CE Mark on LockeT Expects to Receive CE Mark in Third Quarter, 2023
https://www.accesswire.com/764198/RMEDs-Elect...arter-2023
FORT MILL, SC / ACCESSWIRE / June 28, 2023 / Ra Medical Systems, Inc. (NYSE American:RMED) today announced that its Catheter Precision subsidiary has submitted to its European Notified Body the data necessary for determination of CE marking on its LockeT product. Recently the company concluded the final step of three-year shelf-life sterility testing which clears the pathway for achievement of the CE Mark.
"This is yet another milestone for us," commented David Jenkins, RMED's interim CEO. "We are excited about the opportunity for LockeT, not only in the US, but also internationally. We expect to receive the CE Mark on LockeT within the third quarter of this year, and with the CE Mark available, it opens the door for European countries and other countries as well. We believe the international market essentially doubles the market size above and beyond just the US market."
About LockeT
Catheter Precision's LockeT is a suture retention device intended to assist in hemostasis after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA
https://www.accesswire.com/764198/RMEDs-Elect...arter-2023
FORT MILL, SC / ACCESSWIRE / June 28, 2023 / Ra Medical Systems, Inc. (NYSE American:RMED) today announced that its Catheter Precision subsidiary has submitted to its European Notified Body the data necessary for determination of CE marking on its LockeT product. Recently the company concluded the final step of three-year shelf-life sterility testing which clears the pathway for achievement of the CE Mark.
"This is yet another milestone for us," commented David Jenkins, RMED's interim CEO. "We are excited about the opportunity for LockeT, not only in the US, but also internationally. We expect to receive the CE Mark on LockeT within the third quarter of this year, and with the CE Mark available, it opens the door for European countries and other countries as well. We believe the international market essentially doubles the market size above and beyond just the US market."
About LockeT
Catheter Precision's LockeT is a suture retention device intended to assist in hemostasis after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA
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