Dispo Medical holds a variety of certificates of which we, as a company, are very proud.
Below you can find an overview:
CE certificate + NB conformity letter extension MDD-CE (MDR Art. 120)
With the CE certificate, we demonstrate that our medical devices comply with European regulations and safety standards. This is essential for the distribution and use of our products within the European Economic Area.
ISO 13485:2016 certificate
This certificate confirms that our quality management system meets the international requirements for medical devices. It ensures that our processes and products comply with the highest quality and safety standards.
Declaration of Conformity
This declaration of conformity confirms that the disposable tubing systems for medical use (class Is and IIa) from Dispo Medical meet the requirements of the European Medical Devices Directive (93/42/EEC). The products are CE-marked and are manufactured under a certified quality management system (ISO 13485:2016), audited by DEKRA Certification B.V. The validity of the CE certificate has been extended until 31 December 2028 at the latest.
Made in Holland
Dutch-made with a sustainable footprint
Customization
Thanks to in-house production and cleanroom facilities, custom solutions are possible.
Reliability
Almost 40 years of experience, with reliable delivery and consistent quality