Results for “Prime”

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Registry EUDAMED ~1,805 FDA 510(k) ~3 FDA PMA GUDID ~791

Country / market European Union (all) ~1,430 United States ~792

More countries (18)

Germany ~974 Belgium ~150 Netherlands ~107 Türkiye ~59 Italy ~45 Hungary ~42 Liechtenstein ~30 Spain ~28 Austria ~18 Poland ~13 France ~12 Czechia ~7 Ireland ~7 Latvia ~7 Bulgaria ~5 Portugal ~5 Denmark ~3 Luxembourg ~3

Risk class Class I ~1,005 Class IIa ~481 Class IIb ~182 Class III ~70 Class II (US) ~229

More classes (11)

Class A ~23 Class B Class C ~4 Class D IVD General ~5 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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Prime Life Fibers Inc.,United States

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I
Atellica SH Prime

Siemens Healthcare Diagnostics Inc.,United States

Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

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Results for “Prime”

Category (EMDN)

Wearever

Atellica SH Prime