Results for “Non-sterile Bone Screws”

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Registry EUDAMED 640 FDA 510(k) incl. De Novo FDA PMA GUDID

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Risk class Class I Class IIa Class IIb 640 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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Non-sterile Bone Screws

Beijing Libeier Bio-Engineering Institute Co., Ltd.,China Group of variants

Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIb
KangLi

Suzhou Kangli Orthopaedics Instrument Co., Ltd.,China

Active Regimes: CE MDR Registry: EUDAMED Class:IIb

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Results for “Non-sterile Bone Screws”

Category (EMDN)

Non-sterile Bone Screws

KangLi