Home / About DIFRA / Certifications


DIFRA is certified to the requirements of ISO 13485:2003 by the notified body SGS (identification no. 1639) and has Medical CE-mark

Medical CE-mark:

The CE-mark indicates that Instrumentation DIFRA meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval is made by SGS identification no. 1639

TGA approval:

For the Australian market, Instrumentation DIFRA has TGA approval for all the product line.

FDA approuval:

For the USA market, our vestibular line is FDA approved.