Chosen class: III

• Is your device INVASIVE or NON-INVASIVE?

  You answered: Invasive

• Is it NON-SURGICALLY INVASIVE or SURGICALLY INVASIVE?

  You answered: Non-surgically invasive (this means that it enters in the human body but only through a body orifice and without piercing or cutting the skin or membranes)?

• Is it NOT intended for connection to any active medical device?

  You answered: No

• It is intended for connection to an active medical device of class:

  You answered: Class I active medical device

• Is it intended for transient use?

  You answered: Yes

• Is your device ACTIVE?

  You answered: Yes

• Is it therapeutic?

  You answered: Yes

• Does it administer energy to or exchange energy with the human body?

  You answered: Yes, in a potentially hazardous way (consider nature of energy, density of energy, site of the body).

• Is it intended to emit ionizing radiation?

  You answered: Yes

• Is it intended for therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance?

  You answered: Yes

• Is it intended to control or monitor a device that emits ionizing radiation, or does it directly influence the performance a device that emits ionizing radiation?

  You answered: Yes

• Is it intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices?

  You answered: Yes

• Is it intended for controlling, monitoring or directly influencing the performance of active implantable devices?

  You answered: No

• Is it intended for diagnosis and monitoring?

  You answered: No

• Is it a software?

  You answered: No

• Is it intended to administer and/or remove medicinal products, body liquids or other substances to or from the body?

  You answered: No

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

  You answered: No

• 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: No

• 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: Yes

• 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: No

• 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