Results for “PressureGuard Powered Mattresses”

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Registry EUDAMED 150 FDA 510(k) incl. De Novo FDA PMA GUDID 119

Country / market European Union (all) 14 United States 119

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Norway 136 Denmark 14

Risk class Class I 150 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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PressureGuard Powered Mattresses

Span-America Medical Systems, Inc.,United States Group of variants

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I
PressureGuard Powered Mattresses

Span-America Medical Systems, Inc.,United States

Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:I

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deviCERTS Global Medical Device Regulatory Database

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