Goloo A/S – EU directives for medical devices

Goloo A/S products are produced in its own production line. Production takes place at 3L Products in Tommerup, which has great expertise in the production of medical products. The factory is ISO 9001-2015 certified, as well as ISO 14001-2015 certified. Production is shielded from other 3L productions, and handling and packaging of Goloo's products takes place under clean-room-like conditions.

User management :

Complaints and comments from users are evaluated continuously and handled by Goloo A/S on a case-by-case basis. In case of complaints, the customer must state the LOT number, which is printed on each product. In this way, any errors in production can be isolated and repaired/replaced for the customer.

Declaration :

Goloo A/S strives to always meet all medical and legal requirements for the production of medical products. This is done by following EU directives and by self-inspection for each individual product - including hygiene management in connection with raw materials, finished products and packaging.

Goloo's products comply with Regulation 2017/745.

Goloo A/S, March 2020