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Registry EUDAMED 81 FDA 510(k) incl. De Novo FDA PMA GUDID

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Greece 45 Italy 10 Bulgaria 6 Latvia 6 Hungary 5 Cyprus 3 Spain 2 Slovenia 2 Austria 1 France 1

Risk class Class I 81 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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Manufacturer: Yangzhou Super Union Import And Export Co., Ltd× Clear all

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PBT bandage PBT

Yangzhou Super Union Import And Export Co., Ltd,China

Active Regimes: CE MDR Registry: EUDAMED Class:I

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PBT bandage PBT