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Regulatory information

EU MDR CE-marked medical device

OneKnot is a EU MDR CE Class IIb medical device, developed with minimally invasive specialists at Charité – Universitätsmedizin Berlin.

IFU & product details

IFU - Instructions for Use

Clouz OneKnot IFU

Certificates

MDR2017Q-EN - Clouz GmbH 2025-06-12 (pdf)Download
Clouz GmbH - ISO 13485 - EN - 2025-08-18 - MP2016 (pdf)Download
Clouz GmbH - ISO 13485 - DE - 2025-08-18 - MP2016 (pdf)Download


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