This is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos. Similar products on MDALL is classified as Class II.
I'm wondering if this device is an IVDD or nIVDD.
On one hand, no diagnosis is being made, no detection, screening or identification. Not an IVDD? If it's an IVDD, what is the applicable rule?
However, if it's considered to be a nIVDD, which of the nIVVD classification rules is applicable?
I might be wrong here but as far as I can see this product is no IVDD (and consequently no nIVDD), but a medical device meant to store tissues for later administration. I assume that classification rule 5 for medical devices would apply: "A non-invasive device intended for channelling or storing gases, liquids, tissues or body fluids for the purpose of introduction into the body by means of infusion or other means of administration is classified as Class II." (source https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/section-sched1022099.html?txthl=cultured).
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