Results for “HCG PREGNANCY ONE STEP TEST STRIP”

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Registry EUDAMED 28 FDA 510(k) incl. De Novo 14 FDA PMA GUDID

Country / market European Union (all) 28 United States 14

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Romania 22 Germany 2 France 2 Netherlands 2

Risk class Class I Class IIa Class IIb Class III Class II (US) 14

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Class A Class B 21 Class C Class D IVD General 2 IVD Annex II List A IVD Annex II List B IVD for self-testing 5 Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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hCG One Step Pregnancy Test

Sejoy Biomedical Co., Ltd.,China

Active Regimes: CE IVDD 510(k) Registry: EUDAMED Class:IVD for self-testing
One Step HCG Pregnancy Test (Colloidal Gold)

Nantong Diagnos Biotechnology Co., Ltd.,China

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD for self-testing

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Results for “HCG PREGNANCY ONE STEP TEST STRIP”

Category (EMDN)

hCG One Step Pregnancy Test

One Step HCG Pregnancy Test (Colloidal Gold)