Chosen class: III

• Is your device INVASIVE or NON-INVASIVE?

  You answered: Non-invasive

• Is it intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body?

  You answered: Yes

• May it be connected to an active medical device in class IIa or a higher class?

  You answered: No

• Is it intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body cells and tissues, but it is not a blood bag?

  You answered: Yes

• Is it a blood bag?

  You answered: No

• Is it intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body?

  You answered: Yes

• Does the treatment consist of filtration, centrifugation or exchanges of gas, heat?

  You answered: No

• Is your device a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken off from the human body or with human embryos before their implantation or administration into the body?

  You answered: Yes

• Is it intended come into contact with injured skin or mucous membrane?

  You answered: No

• Is your device ACTIVE?

  You answered: No

• Does your device incorporate a medicinal product with an ancillary function?

  You answered: Yes

• Is it used for contraception or prevention of the transmission of sexually transmitted diseases?

  You answered: No

• Is it intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses?

  You answered: No

• Is it intended specifically to be used for disinfecting or sterilising medical devices that are not contact lenses ? NOTE: If it is only intended for cleaning and only by physical action, this rule does not apply.

  You answered: Yes

• Is it a disinfecting solution or washer-disinfector, intended specifically to be used for disinfecting invasive devices, as the end point of processing?

  You answered: Yes

• Is it specifically intended for recording of diagnostic images generated by X-ray radiation?

  You answered: No

• Is it manufactured utilizing tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable?

  You answered: Yes

• Does it incorporate or contain nanomaterials?

  You answered: No

• Is it intended to administer medicinal products by inhalation, being an invasive device with respect to body orifices, other than surgically invasive devices?

  You answered: Yes

• Does its mode of action have an essential impact on the efficacy and safety of the administered medicinal product?

  You answered: Yes

• Is it intended to treat life-threatening conditions?

  You answered: No

• Is it composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body?

  You answered: Yes

• Is it or it products of metabolism, systemically absorbed by the human body in order to achieve the intended purpose?

  You answered: No

• Does it achieve its intended purpose in the stomach or lower gastrointestinal tract and it, or its products of metabolism, is systemically absorbed by the human body?

  You answered: Yes

• Is it applied to the skin or is it applied in the nasal or oral cavity as far as the pharynx, and achieve the intended purpose on those cavities?

  You answered: Yes

• Is it an active therapeutic device with an integrated or incorporated diagnostic function that includes an integrated or incorporated diagnostic function which significantly determines the patient management by the device (example: closed loop systems or automated external defibrillators)?

  You answered: Yes