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Results for “iTOOL”

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Registry EUDAMED 16 FDA 510(k) incl. De Novo FDA PMA GUDID 31

Country / market European Union (all) 13 United States 31

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Poland 11 Germany 2

Risk class Class I 3 Class IIa 16 Class IIb Class III Class II (US) 27

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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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46 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

iTool® ApexpulseTM

Apex (Guangzhou) Tools & Orthopedics Co.,China

Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa
iTool

Apex (Suzhou) Medical Products Company,China Group of variants

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

Apex (Guangzhou) Tools & Orthopedics Co.,China

Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

Showing 41-46 of 46

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