Results for “ECG Cable/Leadwires/Trunk”

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Registry EUDAMED 547 FDA 510(k) incl. De Novo FDA PMA GUDID 83

Country / market European Union (all) 544 United States 83

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Denmark 460 Finland 73 Poland 8 Germany 2 Czechia 1

Risk class Class I 544 Class IIa Class IIb Class III 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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ECG Trunk Cables and Leadwires

GE Healthcare Finland Oy,Finland Group of variants

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I
ECG Leadwires and Trunk Cable

Orantech Inc.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

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Results for “ECG Cable/Leadwires/Trunk”

Category (EMDN)

ECG Trunk Cables and Leadwires

ECG Leadwires and Trunk Cable