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Certificates

Here you can find all current Auditdata Management System Certificates such as ISO 27001 and EC plus Declarations of Conformity for all our products and solutions.

Management System Certificates

ISO 27001

ISO 27001 Certificate

ISO 13485

Auditdata A/S ISO 13485 Certificate
Auditdata A/S ISO 13485 MDSAP Certificate

EC Certificates

Auditdata A/S EC Certificate 93-42-EEC MDD Annex II

Product Certificates

Declarations of Conformity

AuditBase clinic management system
Primus PFU Fitting unit
Primus PHITU Hearing instrument test unit
Primus HIT Pro Hearing instrument test unit
Primus PFU+ Fitting unit Plus
Primus PFU Pro Fitting unit Pro
Primus Ice audiometer
Primus Video Otoscope
Entomed SA201 audiometer
Entomed SA202 audiometer
Entomed SA203 audiometer
Entomed SA204 audiometer
Entomed TY-101 tympanometer
OTOPod MI, M2 audiometer

 

Health Canada

Primus Hit Unit
OTOPod M1 audiometer
OTOPod M2 audiometer
Primus Ice Audiometer
Primus Pro Fitting Unit Pro
Primus HIT hearing instrument test unit
Entomed SA-series audiometers
Primus Video Otoscope

Questions?

If you have any questions as to how we handle information and keep our and your data safe, please get in touch. 

Fill out the form or contact Dan Haugbøl
Director corporate QA/RA and IT/information security
+45 70 20 31 24

Contact us now