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Results for “Sinoscope”

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Registry EUDAMED 38 FDA 510(k) incl. De Novo 1 FDA PMA GUDID

Country / market European Union (all) 38 United States 1

More countries (4)

Germany 28 Austria 8 Belgium 1 Italy 1

Risk class Class I 38 Class IIa Class IIb Class III Class II (US) 1

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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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39 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

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Regime

Registry

Class

Sinoscopes

Hangzhou Hawk Optical Electronic Instruments Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
Sinoscope

Tonglu Youshi Medical Instrument Co., Ltd.,China Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
Medivision Sinoscope

Medivision Scope Service Center, Inc.,United States(FDA applicant)

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

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