Results for “Bone Biopsy Needle”

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Registry EUDAMED 210 FDA 510(k) incl. De Novo 26 FDA PMA GUDID 80

Country / market European Union (all) 166 United States 106

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Italy 95 Germany 48 Türkiye 36 Denmark 21 Ireland 2

Risk class Class I 8 Class IIa 202 Class IIb Class III Class II (US) 65

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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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Bone Marrow Biopsy Needle

Zhejiang CuraWay Medical Technology Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa
Bone Access Needle

Biopsybell SRL,Italy

Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

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Results for “Bone Biopsy Needle”

Category (EMDN)

Bone Marrow Biopsy Needle

Bone Access Needle