Results for “Perfection Plus Eco+ K Files”

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Registry EUDAMED 71 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 71

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Ireland 71

Risk class Class I 71 Class IIa 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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Eco+ K Files

Perfection Plus,United Kingdom Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:I
Eco+ Hand K Files

Perfection Plus,United Kingdom Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:I

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Results for “Perfection Plus Eco+ K Files”

Category (EMDN)

Eco+ K Files

Eco+ Hand K Files