Is the device non-invasive and does it consist of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body?

3.2

in vitro is Latin for “within the glass.” When something is performed in vitro, it happens outside of a living organism.

Yes

No

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Is the device non-invasive and does it modify 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?

3.1a

A route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is taken into the body. Routes of administration are generally classified by the location at which the substance is applied. Common examples include oral and intravenous administration.

Yes

No

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Does the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat?

3.1b

A route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is taken into the body. Routes of administration are generally classified by the location at which the substance is applied. Common examples include oral and intravenous administration.

Yes

No

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