Results for “ASO”

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Registry EUDAMED 796 FDA 510(k) incl. De Novo 33 FDA PMA GUDID 527

Country / market European Union (all) 716 United States 560

More countries (18)

Germany 169 Portugal 151 Netherlands 98 Spain 87 Türkiye 56 France 42 Italy 40 Austria 28 Belgium 25 Poland 19 Greece 13 Norway 13 Romania 12 Sweden 11 Czechia 9 Ireland 6 Denmark 3 Bulgaria 1

Risk class Class I 690 Class IIa 288 Class IIb Class III Class II (US) 17

More classes (11)

Class A Class B 15 Class C 1 Class D IVD General 281 IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) 3 Not classified (FDA)

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