Medical devices

CAMISANA manufactures articles for the medical sector in Clean Room Class ISO 8.
In this production space, subject to temperature, humidity and air pressure control, with planned checks for the presence of particulates and bacteria, using only platinum-catalysed silicone in certified medical grade (USP Class VI minimum requirement). We produce, by using a compression moulding machine for HCR moulding and an injection moulding machine for LSR moulding, components for medical devices and objects for the medical and paramedical sector such as:

• Custom moulded and moulded parts for medical equipment and appliances;
• Valves, membranes and pump seals for fluid and powder handling;
• Caps, mats, plates and accessories for the laboratory;
• Masks and respirators;
• Functional and aesthetic prostheses;
• Personal devices
• Every part according to customer design.

All our products are manufactured in compliance with ISO9001-2015 and ISO13485:2016 (LINK ALLA

We are a company with more than 40 years of experience, employing qualified personnel. We are able to examine, develop and manufacture the components of your medical devices, suggesting the most suitable raw material, following and defining the production processes in compliance with current regulations.

We have a wide range of medical grade silicones that allow us to manufacture your components according to the required technical specifications

• Hardness from 10 Sh A+-5 to 90 Sh A +-5
• Temperature resistance from -70°C (down to -110°C) to 200°C (up to 300°C)
• All colours are available
• USP CLSSE VI, FDA or European Pharmacopoeia

For more information regarding the production of medical and biomedical devices in the Clean Room, one of our technicians is at your disposal at +39 035882371 or write to info@camisana.it

• Read our in-depth article on Silicone moulding