Results for “GoldCath”

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Registry EUDAMED 18 FDA 510(k) incl. De Novo FDA PMA GUDID

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Türkiye 18

Risk class Class I Class IIa 18 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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GoldCath

Demersan Biyoteknoloji İmalat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇,Türkiye Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:IIa

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