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Results for “High-speed Air Turbine Handpieces”

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Registry EUDAMED 27 FDA 510(k) incl. De Novo 3 FDA PMA GUDID 1

Country / market European Union (all) 27 United States 3

More countries (6)

Ireland 10 France 9 Czechia 4 Greece 2 Hungary 1 Portugal 1

Risk class Class I 2 Class IIa 27 Class IIb Class III 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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29 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

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High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H)

J. Morita Usa, Inc.,FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:I
High-speed Air Turbine Handpieces

Foshan Snyder Medical Equipment Co., Ltd,China Group of variants

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

Showing 21-29 of 29

deviCERTS Global Medical Device Regulatory Database

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