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Registry EUDAMED 189 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 148

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France 147 Türkiye 41 Italy 1

Risk class Class I Class IIa 189 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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189 devices foundsorted by relevance

Manufacturer: Hangzhou Westlake Biomaterial Co., Ltd.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

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Orthodontic Wires

Hangzhou Westlake Biomaterial Co., Ltd.,China Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:IIa
Orthodontic Brackets

Hangzhou Westlake Biomaterial Co., Ltd.,China Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:IIa

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deviCERTS Global Medical Device Regulatory Database

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