Results for “Automatic Core Biopsy Instrument”

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Registry EUDAMED 738 FDA 510(k) incl. De Novo 3 FDA PMA GUDID 171

Country / market European Union (all) 737 United States 174

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Germany 715 Italy 15 Spain 4 Netherlands 3 Türkiye 1

Risk class Class I Class IIa 738 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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Automatic Core Biopsy Instrument

Zhejiang CuraWay Medical Technology Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
Disposable Automatic Core Biopsy Instruments

Suzhou Leapmed Healthcare Corporation,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa

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Results for “Automatic Core Biopsy Instrument”

Category (EMDN)

Automatic Core Biopsy Instrument

Disposable Automatic Core Biopsy Instruments