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Results for “Direct Bilirubin (DBil)”

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Registry EUDAMED 39 FDA 510(k) incl. De Novo 3 FDA PMA GUDID 6

Country / market European Union (all) 35 United States 9

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Germany 33 Austria 1 Netherlands 1 Türkiye 1

Risk class Class I Class IIa Class IIb Class III Class II (US) 9

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Class A Class B Class C Class D IVD General 36 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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45 devices foundsorted by relevance

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Bilirubin Direct (DBIL)

Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇,Türkiye

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
Direct Bilirubin (DBIL) Test Kit (DCA)

Biobase Biodustry(Shandong) Co., Ltd.,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
Direct Bilirubin (DBil)

Maccura Biotechnology Co., Ltd.,China

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

Showing 41-45 of 45

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