Results for “BLUEDIAMOND IMPLANT”

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Registry EUDAMED 256 FDA 510(k) incl. De Novo 2 FDA PMA GUDID 165

Country / market European Union (all) 107 United States 167

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Risk class Class I 4 Class IIa 2 Class IIb 103 Class III Class II (US) 149

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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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Bluediamond Implant

Megagen Implant Co., Ltd.,South Korea Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
BLUEDIAMOND Bone Profiler Kit Case

Megagen Implant Co., Ltd.,South Korea

Active Regimes: CE MDR Registry: EUDAMED Class:I

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Results for “BLUEDIAMOND IMPLANT”

Category (EMDN)

Bluediamond Implant

BLUEDIAMOND Bone Profiler Kit Case