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Registry EUDAMED 161 FDA 510(k) incl. De Novo FDA PMA 2 GUDID

Country / market European Union (all) 159 United States 2

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Denmark 156 Germany 3

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

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Class A 86 Class B Class C 8 Class D IVD General 65 IVD Annex II List A IVD Annex II List B 2 IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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163 devices foundsorted by relevance

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd× Clear all

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MagnisDx NGS Prep System

Agilent Technologies Singapore (International) Pte Ltd,Singapore

Active Regimes: CE IVDR Registry: EUDAMED Class:A
HER2 Iqfish Pharmdx

Agilent Technologies Singapore (International) Pte Ltd,Singapore

Active Regimes: PMA Registry: PMA Class:III
Hercap Test

Agilent Technologies Singapore (International) Pte Ltd,Singapore

Active Regimes: PMA Registry: PMA Class:III

Showing 161-163 of 163

deviCERTS Global Medical Device Regulatory Database

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