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
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DNV Addendum-KEN Hygiene Systems (002)-signed by all parties-20240227
26. Feb 2024
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DNV Clarification for KEN
16. Jun 2021
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EC Certificate and product list
6. May 2021
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Free sales Certificate-KEN
19. May 2022
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Free sales Certificate-MAT – LD & LC
19. May 2022
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MDR Manufacturer declaration KEN
1. Mar 2024
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NB confirmation letter C674113 – signed
27. Feb 2024
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REACH Compliance Statement 2023-01-05
5. Jan 2024
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RoHS Declaration of conformity
19. Aug 2024
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WEEE Certificate
3. Sep 2010
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ISO certificates
ISO 9001 KEN
3. Jul 2024
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ISO 14001 KEN
3. Jul 2024
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ISO 13485 KEN
13. Jun 2023
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Local certificates
Anslutningsbevis El-Kretsen 2023, KEN HYGIENE SYSTEMS AS, Sverige filial (SE)
2. Jan 2023
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Anslutningsbevis FTI 2023, KEN HYGIENE SYSTEMS AS, Sverige filial
2. Jan 2023
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CertificateNPA_KEN SE_2024
1. Jan 2024
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Sikkerhedsdatablad BluKat® Sterilizing Solution 13102022 Rev 02_03
13. Oct 2024
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Virksomhed Godkendelse Refrigeration (DK)
21. Oct 2024
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