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Registry EUDAMED 101 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 101

More countries (18)

Spain 32 Austria 10 Germany 8 Belgium 7 Estonia 7 Czechia 5 Croatia 5 Latvia 5 Slovakia 5 Portugal 4 Lithuania 3 Denmark 2 Ireland 2 Italy 2 Bulgaria 1 Cyprus 1 Finland 1 Hungary 1

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

More classes (11)

Class A Class B Class C Class D IVD General 88 IVD Annex II List A IVD Annex II List B IVD for self-testing 13 Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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