Results for “Helix”

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Registry EUDAMED 769 FDA 510(k) incl. De Novo 73 FDA PMA GUDID 1,229

Country / market European Union (all) 350 United States 1,301

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Türkiye 404 Germany 106 France 70 Netherlands 54 Italy 36 Spain 31 Belgium 29 Ireland 11 Austria 8 Poland 4 Hungary 1

Risk class Class I 217 Class IIa 287 Class IIb 116 Class III 246 Class II (US) 1,022

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Class A Class B 62 Class C Class D IVD General 1 IVD Annex II List A IVD Annex II List B IVD for self-testing 2 Active implantable (AIMDD) Unclassified (FDA) 1 Not classified (FDA)

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Helix

Ear Technic Hearing Aids,Türkiye Group of variants

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

Ear-Technic GmbH,Germany

Active Regimes: CE MDR Registry: EUDAMED Class:IIa

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