Results for “Polux”

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Registry EUDAMED 621 FDA 510(k) incl. De Novo 1 FDA PMA GUDID 296

Country / market European Union (all) 617 United States 297

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Netherlands 617

Risk class Class I Class IIa 617 Class IIb Class III Class II (US) 5

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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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Polux Pro

BrosMed Medical Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa

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Results for “Polux”

Category (EMDN)

Polux Pro