Konformitätserklärungen

MDR EU-Declaration of Conformity for Medical Devices

MDR Class I

(PDF | 396.3 KB)

MDR Class IIa, IIb

(PDF | 378.92 KB)

MDR Class Is

(PDF | 367.42 KB)

MDR UK-Declaration of Conformity for Medical Devices

MDR Class 1

(PDF | 190.32 KB)

ISO Zertifikate

EN ISO 13485:2016

(PDF | 369.95 KB)

ISO 9001:2015

(PDF | 960.2 KB)

MDR Statement of System and Procedure Pack Producer

(PDF | 177.9 KB)