Results for “Balloon Ureteral Dilator”

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Registry EUDAMED 156 FDA 510(k) 3 FDA PMA GUDID 4

Country / market European Union (all) 133 United States 7

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Germany 111 Ireland 11 Türkiye 11 Croatia 2 Italy 2 Portugal 2 Greece 1 Spain 1 Finland 1 Hungary 1 Romania 1

Risk class Class I 4 Class IIa 152 Class IIb Class III Class II (US) 3

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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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Balloon Ureteral Dilator

Alton (Shanghai) Medical Instruments Co., Ltd.,China

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Ureteral Balloon Dilator

Biorad Medisys Pvt, Ltd.,India

Active Regimes: CE MDR Registry: EUDAMED Class:IIa

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Results for “Balloon Ureteral Dilator”

Category (EMDN)

Balloon Ureteral Dilator

Ureteral Balloon Dilator