Am I correct in understanding that Eugeni reader & test will require additional registration with the Spanish Regulator - I don't think Eugeni fits into a CE Class I medical device which requires no additional paperwork for Spain. I think the it will fit into Class IIa ?
(e.g. see here: https://www.obelis.net/registration-in-spain/ )
If that's the case and there's additional paperwork/registration required - has it been completed ?
I guess a similar pondering to my comment the other day:
https://hotcopper.com.au/posts/56855281/single
SPAIN AND PORTUGAL DISTRIBUTION, page-18
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