QUALITY & REGULATIONS

To us quality is meeting our customer’s needs and exceeding their expectations. We believe we are especially apt to that task due to our combination of clinical experience and manufacturing competence. We are very proud of our in-house manufacturing which is based in our production facility in Kongsvinger, Norway.

 

The in-house factor, and our long experience with product development and clinical use, has proved to be a winning formula for us. We simply believe this gives us an edge in meeting our customers’ requirements for high quality products. 

Certificates 

MDD & MDR Declarations of conformity

Click the name of the product family to access the declaration of conformity according to Annex II Excluding section 4 of Council Directive of 93/42/EEC on medical devices, as amended. All class I our products meet the MDR. 

Class IIa	Class I
MALU Hooks & stops Rotation wedges Mini Lock	Retractors Retainer boxes Napkin holders Mirrors Impression trays

ADVERSE EVENTS

If you have experienced an adverse event with any of our products please contact us immediately  at +47 628 14 898