Results for “SWAROPLATE”

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Registry EUDAMED 29 FDA 510(k) incl. De Novo FDA PMA GUDID 44

Country / market European Union (all) 29 United States 44

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France 29

Risk class Class I Class IIa Class IIb 29 Class III Class II (US) 44

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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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Swaroplate

Nissha Medical Technologies Ltd,United Kingdom Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:IIb

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Results for “SWAROPLATE”

Category (EMDN)

Swaroplate