Results for “Coronary angioplasty catheter Rapid Exchange, River”

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Registry EUDAMED 218 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 218

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Poland 104 Spain 76 Italy 38

Risk class Class I Class IIa Class IIb Class III 218 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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Coronary angioplasty catheter Rapid Exchange, River

Balton Sp. z o.o.,Poland Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:III
Coronary angioplasty catheter non-compliant type Rapid Exchange (RX), River NC

Balton Sp. z o.o.,Poland Group of variants

Active Regimes: CE MDD Registry: EUDAMED Class:III

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Results for “Coronary angioplasty catheter Rapid Exchange, River”

Category (EMDN)

Coronary angioplasty catheter Rapid Exchange, River

Coronary angioplasty catheter non-compliant type Rapid Exchange (RX), River NC