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Registry EUDAMED 41 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 38

More countries (16)

France 5 Germany 4 Italy 4 Finland 3 Hungary 3 Norway 3 Romania 3 Sweden 3 Austria 2 Bulgaria 2 Spain 2 Ireland 2 Netherlands 2 Denmark 1 Croatia 1 Lithuania 1

Risk class Class I Class IIa 41 Class IIb Class III Class II (US)

More classes (11)

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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