Results for “UREA - Urea UV / Urea UV (Urease/GLDH)”

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Registry EUDAMED 4 FDA 510(k) incl. De Novo FDA PMA GUDID

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Germany 3 Italy 1

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Class A Class B 3 Class C Class D IVD General 1 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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Urea Urease GLDH-UV LS

MTD Diagnostics srl,Italy

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
Urea Kit (Urease-GLDH, UV Method)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:B

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Results for “UREA - Urea UV / Urea UV (Urease/GLDH)”

Category (EMDN)

Urea Urease GLDH-UV LS

Urea Kit (Urease-GLDH, UV Method)