Certificates
Download KEN certificates
Our machines comply with all relevant EU directives such as Council Directive 93/42 / EEC (Medical Device Directive) and Council Directive 89/392 / EEC (Machinery Directive) and our Business Quality Management system is certified according to EN ISO 9001: 2015 EN ISO 13485: 2016 and EN ISO 14001: 2015.
Our disinfecting instrument washers and bedpan washers have product certification in accordance with article 11.3 of the Medical Devices Directive as well as Annex II.
General certificates
Code of conduct ENG
29. Jun 2024
Download DNV Addendum-KEN Hygiene Systems (002)-signed by all parties-20240227
26. Feb 2024
Download DNV Clarification for KEN
16. Jun 2021
Download EC Certificate and product list
6. May 2021
Download Free sales Certificate-KEN
19. May 2022
Download Free sales Certificate-MAT – LD & LC
19. May 2022
Download MDR Manufacturer declaration KEN
1. Mar 2024
Download NB confirmation letter C674113 – signed
27. Feb 2024
Download REACH Compliance Statement 2023-01-05
5. Jan 2024
Download RoHS Declaration of conformity
19. Aug 2024
Download WEEE Certificate
3. Sep 2010
Download ISO certificates
Local certificates
Anslutningsbevis El-Kretsen 2023, KEN HYGIENE SYSTEMS AS, Sverige filial (SE)
2. Jan 2023
Download Anslutningsbevis FTI 2023, KEN HYGIENE SYSTEMS AS, Sverige filial
2. Jan 2023
Download CertificateNPA_KEN SE_2024
1. Jan 2024
Download Sikkerhedsdatablad BluKat® Sterilizing Solution 13102022 Rev 02_03
13. Oct 2024
Download Virksomhed Godkendelse Refrigeration (DK)
21. Oct 2024
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