OSYPKA AG gains CE mark for class III pacing electrode

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OSYPKA AG, a medical device company based in Rheinfelden, Germany, has received the CE mark under the European Union’s Medical Device Regulation (MDR) for a class III cardiac pacing electrode.

“This is a new milestone that is also valuable for our OEM customers, as we cover all processes, from design idea to patient application according to the highest standards,” says the company’s CEO Nicola Osypka.

Formed in 1977, OSYPKA AG develops and manufactures medical devices including ablation catheters, valvuloplasty balloons and snare catheters, and offers turnkey services including regulatory approval to contract customers worldwide.


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