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Specjalistyczne linie wyrobów medycznych uzupełniane suplementami diety oraz kosmetykami.

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ul. J. Marcika 12, Kraków

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Marcika Street 4a, Kraków Poland

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GOFARM  >  Gofarm   >  We’ve got this! All Gofarm medical devices are in the process of certification according to MDR 2017/745!

We’ve got this! All Gofarm medical devices are in the process of certification according to MDR 2017/745!

We are happy and proud to announce the signing of an agreement with the notified body PCBC SA regarding the certification according to MDR 2017/745 of our portfolio, over 30 Gofarm medical devices!

This agreement, together with the certification schedule for individual groups of medical devices, ensures the continuity of sales of our products until the end of 2028 and in subsequent years.

The largest line of ENT (Ear-Throat-Nose) medical devices in Poland in the Private Label formula,
including products containing icelandic lichen will soon be certified for compliance
with European regulations MDR 2017/745.

We expect the first MDR 2017/745 certificates very soon!

We would like to express our special thanks to the Gofarm Regulatory Department– a fantastic team of Krakow experts who have been preparing the certification process of Gofarm’s diverse and rich portfolio of medical products for several years!

Gofarm as an expert on the European Union market specializing in R&D and regulatory services
and production of substance medical devices, under the supervision of the Polish notified body – PCBC SA – ensures its Customers, Partners and Patients the highest quality of products and their safety of use.

Are you interested in Private Label medical devices undergoing certification for compliance with MDR 2017/745? Contact us!

This website presents various products available in private label formula: Medical devices, cosmetics and dietary supplements. For medical devices on the website we provide the following information:

This is a Medical device.
Use it according to the instructions of use or label.

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