Results for “Sterile High-pressure Angiographic Syringes for Single-use”

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Registry EUDAMED 181 FDA 510(k) incl. De Novo 1 FDA PMA GUDID 166

Country / market European Union (all) 181 United States 167

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Risk class Class I Class IIa 181 Class IIb Class III Class II (US) 1

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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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Sterile High-pressure Angiographic Syringes for Single-use

Shenzhen Boon Medical Supply Co., Ltd.,China Group of variants

Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

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