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Registry EUDAMED 224 FDA 510(k) incl. De Novo 2 FDA PMA GUDID

Country / market European Union (all) 224 United States 2

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Germany 224

Risk class Class I Class IIa Class IIb Class III 224 Class II (US) 2

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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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226 devices foundsorted by relevance

Manufacturer: Suzhou Microport Orthorecon Co., Ltd.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

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Evolution Mpx™ Tibial Insert

Suzhou Microport Orthorecon Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:III
EVOLUTION MPX™ Total Knee System

Suzhou Microport Orthorecon Co., Ltd.,China

Active Regimes: 510(k) Registry: 510(k) Class:II
MedalOne Total Knee System

Suzhou Microport Orthorecon Co., Ltd.,China

Active Regimes: 510(k) Registry: 510(k) Class:II

Showing 221-226 of 226

deviCERTS Global Medical Device Regulatory Database

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