Results for “System 2000 - Primo”

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Registry EUDAMED 788 FDA 510(k) incl. De Novo FDA PMA GUDID

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Austria 483 Ireland 305

Risk class Class I 788 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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System 2000 - Primo

Arjohuntleigh AB,Sweden Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
System 2000 - Primo Ferro

Arjohuntleigh AB,Sweden Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I

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Results for “System 2000 - Primo”

Category (EMDN)

System 2000 - Primo

System 2000 - Primo Ferro