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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

More countries (18)

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

More classes (11)

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 UDI-DI 07613378199653

Sigvaris AG,Switzerland

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I
143 variants
- Essential COMFORTABLE 320245
- Essential COMFORTABLE 320246
- Essential COMFORTABLE 320250
- Essential COMFORTABLE 320327
- Essential COMFORTABLE 320331
- Essential COMFORTABLE 320356
- Essential COMFORTABLE 320362
- Essential COMFORTABLE 320367
- Essential COMFORTABLE 320408
- Essential COMFORTABLE 320435
- Essential COMFORTABLE 320436
- Essential COMFORTABLE 320440
- Essential COMFORTABLE 320521
- Essential COMFORTABLE 320525
- Essential COMFORTABLE 320560
- Essential COMFORTABLE 320603
- See all variants of this device

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