Results for “Kit composed of a "PEEL-AWAY" percutaneous introducer set + threshold cable”

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Registry EUDAMED 8 FDA 510(k) incl. De Novo FDA PMA GUDID

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Risk class Class I Class IIa 8 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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Kit composed of a PEEL-AWAY percutaneous introducer set + threshold cable

FIAB S.p.A.,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa

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Results for “Kit composed of a "PEEL-AWAY" percutaneous introducer set + threshold cable”

Category (EMDN)

Kit composed of a PEEL-AWAY percutaneous introducer set + threshold cable