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Registry EUDAMED 33 FDA 510(k) incl. De Novo FDA PMA GUDID

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Risk class Class I 33 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: G-5 Florida LLC dba Anjon Medical Technologies, dba Anjon Holdings, dba Anjon, dba Generix Medical.× Clear all

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Anjon Bremer Halo System

G-5 Florida LLC dba Anjon Medical Technologies, dba Anjon Holdings, dba Anjon, dba Generix Medical.,United States Group of variants

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

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