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Results for “ETEST® Ertapenem (ETP)”

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Registry EUDAMED 2 FDA 510(k) incl. De Novo FDA PMA GUDID 3

Country / market European Union (all) 1 United States 3

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France 1

Risk class Class I Class IIa Class IIb Class III Class II (US) 3

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Class A Class B 1 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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4 devices foundsorted by relevance

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Class

ETEST® Ertapenem (ETP)

Biomerieux, Inc.,FDA registration: United States

Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:II
ETEST® Ertapenem (ETP)

Biomerieux SA,France

Active Regimes: CE IVDR Registry: EUDAMED Class:B
ETEST® Ertapenem (ETP)

Biomerieux, Inc.,FDA registration: United States Group of variants

None Registry: GUDID Class:II

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