Instructions for use

In accordance with the Medical Device Regulation (MDR), instructions for use for the CoroPrevention will be supplied on this page. Aside from information about the product (name/trademark, product ID) and the manufacturer (name, address, contact information), information about the following is provided:

• intended purpose;
• indications and contra-indications;
• patient target group and intended users;
• specification of the clinical benefit to be expected;
• availability of the summary of safety and clinical performance (high-risk devices);
• the device's performance characteristics;
• specifications which are required for appropriate use of the device;
• sterilization, final assembly, calibration, cleaning and disinfection;
• necessary qualifications for users;
• any reconditioning procedures;
• storage, transport, durability;
• combination with other devices, including accessories;
• maintenance and repair;
• symbols and identification colors.