Certificates

We are internationally certified

Quality and reliability in manufacturing medical devices


 

 

ISO 13485:2016
ISO 13485:2016 is a standard for the design and manufacture of medical equipment. It is an independent standard certification that is generally harmonized with ISO 9001:2015. The standard has been prepared in accordance with the European Commission with a view to the essential requirements of EU directives for medical devices and CE marking.

For Arctiko, the ISO 13485:2016 is a quality management system ensuring that our products meet the EU directive 93/42/EEC for medical devices.

Download Download

 

 

 

ISO 9001:2015
ISO 9001:2015 is the most widely used International standard in the world. It streamlines and documents Arctiko’s working processes and ensures that production always meets the high quality expectations of Arctiko’s partners.

Download Download

 


 

 

 

MEDICAL DEVICE DIRECTIVE
EU directive 93/42/EEC for medical devices & CE marking for Class II equipment.

Download Download

 

 

Close Up 003

 

 

 

FDA
Arctiko is registered and has listed the following medical device with the U.S. Food and Drug Administration for FY 2016 Pursuant to Title 21, 807 et seq. of the United States Code of Federal Regulations.

Download Download

 

 

Internationally certified


 

 

 

ETL
Arctiko products are approved according to the following standard(s): UL 471 issued: 2010/11/24 Ed.: 10 Rev: 2014/11/17 Commercial Refrigerators and Freezers.

CSA C22.2#120 Issued: 2013/03/01 Ed: 4 Refrigeration Equipment

Download Download

 

 

True cooling specialist

ARCTIKO is rapidly becoming the first and best choice when it comes to delivering advanced and customized cooling and freezing solutions - primarily in healthcare and life sciences. 

Follow us
Copyright Arctiko © | All rights reserved
Hi, my name is Casper Morsing

I'm ready to help you if you have any questions. Call me at +1 615 988 7000 or e-mail sales@arctiko.com