Results for “Safety Pen Needles”

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Registry EUDAMED 35 FDA 510(k) incl. De Novo 4 FDA PMA GUDID 43

Country / market European Union (all) 32 United States 47

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Spain 12 Austria 10 Germany 5 Netherlands 2 Belgium 1 Ireland 1 Italy 1

Risk class Class I Class IIa 35 Class IIb Class III Class II (US) 47

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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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Dual Safety Pen Needles

Sandstone Medical(Suzhou) Inc.,China

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Safety Pen Needles

Sandstone Medical(Suzhou) Inc.,China

Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

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Results for “Safety Pen Needles”

Category (EMDN)

Dual Safety Pen Needles

Safety Pen Needles