Results for “Sphera Duo Neonatal with Reservoir”

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

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Austria Belgium Bulgaria Croatia Cyprus Czechia Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Slovenia Spain Sweden Iceland Liechtenstein Norway Türkiye Northern Ireland

Risk class Class I 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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