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Registry EUDAMED 351 FDA 510(k) incl. De Novo FDA PMA GUDID

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Türkiye 318 Germany 33

Risk class Class I 351 Class IIa 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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Manufacturer: Aidite (Shenzhen) Medical Technology Co., Ltd.× Clear all

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Aidite (Shenzhen) Medical Technology Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I

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