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Certification

We are keeping a quality management system in agreement to the ISO 13485 and are certificated by TUV according to Appendix II, section 3 of the Guideline 93/42/EWG of the Council of Medicine Products.
The Hipax products are freed by the FDA to be marketed in the USA.

Certificate ISO 13485:2003 (pdf file, 400 KB)

CE Certificate according to 93/42 EWG (pdf file, 350 KB)

FDA (pdf file, 200 KB)

 

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