Results for “SOMACORE VERIFY”

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Registry EUDAMED 62 FDA 510(k) incl. De Novo FDA PMA GUDID 14

Country / market European Union (all) 62 United States 14

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Germany 62

Risk class Class I Class IIa 62 Class IIb 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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Somacore Verify

Biopsybell SRL,Italy Group of variants

Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa
Somacore Verify S

Biopsybell SRL,Italy Group of variants

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

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Results for “SOMACORE VERIFY”

Category (EMDN)

Somacore Verify

Somacore Verify S