Results for “Comfort”

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Registry EUDAMED ~2,000 FDA 510(k) ~1 FDA PMA GUDID ~507

Country / market European Union (all) ~1,817 United States ~508

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Germany ~1,519 Austria ~50 Italy ~37 Belgium ~32 Netherlands ~32 Sweden ~30 Northern Ireland ~30 Czechia ~22 Poland ~21 France ~19 Hungary ~14 Denmark ~13 Romania ~12 Spain ~4 Ireland ~4 Finland ~3 Türkiye ~3 Portugal ~2

Risk class Class I ~1,861 Class IIa ~77 Class IIb ~21 Class III Class II (US) ~38

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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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Essential COMFORTABLE

Sigvaris AG,Switzerland

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

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Results for “Comfort”

Category (EMDN)

Essential COMFORTABLE