Results for “Disposable Insulin Pen Needles”

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Registry EUDAMED 15 FDA 510(k) incl. De Novo FDA PMA GUDID

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Spain 9 Greece 6

Risk class Class I Class IIa 15 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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Disposable Insulin Pen Needles

Jiangsu Kanghua Medical Equipment Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
bexen medical

Jiangsu Caina Medical Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa

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Results for “Disposable Insulin Pen Needles”

Category (EMDN)

Disposable Insulin Pen Needles

bexen medical