Results for “Gauze Products with X-ray Detectable Element”

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Registry EUDAMED 103 FDA 510(k) incl. De Novo FDA PMA GUDID

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Germany 31 France 29 Netherlands 15 Portugal 9 Poland 7 Sweden 7 Ireland 3 Belgium 2

Risk class Class I 36 Class IIa 67 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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Gauze products with X-ray detectable element

Winner Medical Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Gauze Products without X-ray Detectable Element

Winner Medical Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I

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Results for “Gauze Products with X-ray Detectable Element”

Category (EMDN)

Gauze products with X-ray detectable element

Gauze Products without X-ray Detectable Element