Results for “Urine Collection Bags”

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Registry EUDAMED 68 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 43

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Germany 14 Portugal 11 Italy 7 Poland 4 Austria 1 Bulgaria 1 Greece 1 Spain 1 France 1 Lithuania 1 Netherlands 1

Risk class Class I 68 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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Urine collection systems and bags

Produtos Médicos Hospitalares, SA,Portugal Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
Urine Collection Bags with/without volume meter

Poly Medicure Limited,India Group of variants

Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:I

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Results for “Urine Collection Bags”

Category (EMDN)

Urine collection systems and bags

Urine Collection Bags with/without volume meter