Results for “Cem-Implant”

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Registry EUDAMED 781 FDA 510(k) incl. De Novo 21 FDA PMA GUDID 499

Country / market European Union (all) 633 United States 520

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Poland 435 Spain 83 France 35 Portugal 26 Germany 23 Greece 9 Netherlands 9 Belgium 7 Austria 6 Türkiye 1

Risk class Class I 39 Class IIa 8 Class IIb 544 Class III 44 Class II (US) 470

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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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IH Cement Abutment

SEWONMEDIX Inc.,South Korea Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:IIb
Cem-Implant

B.J.M. Laboratories Ltd.,Israel

Active Regimes: CE MDR Registry: EUDAMED Class:IIa

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Results for “Cem-Implant”

Category (EMDN)

IH Cement Abutment

Cem-Implant