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Registry EUDAMED 20 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 17

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Italy 5 Spain 4 Germany 3 Greece 2 Denmark 1 Netherlands 1 Poland 1

Risk class Class I Class IIa Class IIb 4 Class III 16 Class II (US)

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Class A Class B 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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20 devices foundsorted by relevance

Manufacturer: Alfa Intes Industria Terapeutica Splendore S.r.l.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

Status

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Class

Idroflog

Alfa Intes Industria Terapeutica Splendore S.r.l.,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:III
Oftaial

Alfa Intes Industria Terapeutica Splendore S.r.l.,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
Oftaial Plus

Alfa Intes Industria Terapeutica Splendore S.r.l.,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIb

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