Results for “Scoreflex”

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Registry EUDAMED 295 FDA 510(k) incl. De Novo 1 FDA PMA 1 GUDID 141

Country / market European Union (all) 294 United States 143

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Netherlands 115 Denmark 112 Germany 26 Spain 24 Italy 17

Risk class Class I Class IIa 232 Class IIb Class III 87 Class II (US) 3

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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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Scoreflex PTA

OrbusNeich Medical (Shenzhen) Co., Ltd,China Group of variants

Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

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Results for “Scoreflex”

Category (EMDN)

Scoreflex PTA