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Registry EUDAMED FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all)

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Belgium Bulgaria Germany Czechia Austria Cyprus Croatia Italy Iceland Ireland Lithuania Latvia Hungary Greece Denmark France Poland Estonia Liechtenstein

Risk class Class I Class IIa Class IIb Class III Class II (US)

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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