Results for “ProSeal Non-Vented Bag Spike with ProSeal Injection Site (DMA Compatible)”

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Registry EUDAMED 6 FDA 510(k) incl. De Novo FDA PMA GUDID

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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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ProSeal Non-Vented Bag Spike with ProSeal Injection Site (DMA Compatible)

Epic International (Thailand) Co., Ltd.,Thailand Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I

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