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Results for “Optimas”

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Registry EUDAMED 36 FDA 510(k) incl. De Novo 1 FDA PMA GUDID 1

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

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Türkiye 34 Italy 2

Risk class Class I 2 Class IIa 34 Class IIb Class III Class II (US) 2

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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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38 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

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Regime

Registry

Class

Optimas

Optimas Medikal Urunler Sanayi Ticaret Limited Sirketi,Türkiye Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:IIa
OptiMask

Praesidia S.r.l.,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
OptimasMax platform AG613190A

Inmode MD, Ltd.,Israel(FDA applicant)

None Registry: GUDID Class:II
Optimas MAX System

InMode, Ltd.,FDA registration: Israel

Active Regimes: 510(k) Registry: 510(k) Class:II

Showing 21-38 of 38

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