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Regulatory information

EU MDR CE Class IIb medical device

OneKnot Polyester is a EU MDR CE Class IIb medical device.

Manufacturer: Clouz GmbH, Schinkestr. 9, 12047 Berlin, Germany

SRN: DE-MF-000007330 

Notified Body: DQS Medizinprodukte GmbH (NB 0297)


EU Declaration of Conformity for this device is available upon request at info@clouz.one


Instructions for use - IFU

IFU - Instructions for Use

IFU - Instructions for Use

IFU - Instructions for Use

OneKnot IFU

Gebrauchsanweisungen - IFU

IFU - Instructions for Use

IFU - Instructions for Use

OneKnot Gebrauchsanweisungen

Medical product certificates

MDR2017Q-EN - Clouz GmbH 2025-06-12 (pdf)Herunterladen
Clouz GmbH - ISO 13485 - EN - 2025-08-18 - MP2016 (pdf)Herunterladen
Clouz GmbH - ISO 13485 - DE - 2025-08-18 - MP2016 (pdf)Herunterladen
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Clouz GmbH | Schinkestr. 9 | 12049 Berlin | Germany

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