Results for “FOB Rapid Test Cassette”

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Registry EUDAMED 40 FDA 510(k) FDA PMA GUDID 2

Country / market European Union (all) 40 United States 2

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Spain 19 Germany 15 Ireland 2 Austria 1 Cyprus 1 France 1 Romania 1

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

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Class A Class B 1 Class C 15 Class D IVD General 21 IVD Annex II List A IVD Annex II List B IVD for self-testing 3 Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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DiaRapid FOB Rapid Test Cassette

Hangzhou Alltest Biotech.Co., Ltd.,China

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD for self-testing
FOB Rapid Test （Feces）

Sejoy Biomedical Co., Ltd.,China

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

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Results for “FOB Rapid Test Cassette”

Category (EMDN)

DiaRapid FOB Rapid Test Cassette

FOB Rapid Test （Feces）