Results for “Single-use Containers for Human Venous Blood Specimen Collection”

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Registry EUDAMED 140 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 3

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Türkiye 137 Germany 3

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

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Class A 140 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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Single-use Containers for Human Venous Blood Specimen Collection

Hebei Xinle Sci&Tech Co., Ltd.,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:A

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