Results for “GenSure HCG Pregnancy Rapid Test”

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Registry EUDAMED 24 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 24

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Spain 22 Poland 2

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Class A Class B 24 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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EuroGen HCG Pregnancy Rapid Test

GenSure Biotech Inc.,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:B
GenSure HCG Pregnancy Rapid Test

GenSure Biotech Inc.,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:B

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Results for “GenSure HCG Pregnancy Rapid Test”

Category (EMDN)

EuroGen HCG Pregnancy Rapid Test

GenSure HCG Pregnancy Rapid Test