EU MDR Compliance
Classification: OneKnot® Polyester is a EU MDR CE Class IIb medical product.
SRN: DE-MF-000007330
Legal manufacturer: Clouz GmbH, Schinkestr. 9, 12047 Berlin, Germany
Notified Body: DQS Medizinprodukte GmbH (NB 0297)
Download resources
MDR2017Q-EN - Clouz - 2025-06-12
ISO13485 English - 2026-06-28 - MP2021
ISO13485 Deutsch - 2026-06-28 - MP2021
Summary of Safety and Clinical Performance
EU Declaration of Conformity is available upon request at info@clouz.one