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Registry EUDAMED 291 FDA 510(k) incl. De Novo 1 FDA PMA GUDID 11

Country / market European Union (all) 291 United States 12

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Spain 240 Netherlands 50 Greece 1

Risk class Class I Class IIa Class IIb Class III Class II (US) 12

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Class A 2 Class B Class C Class D IVD General 289 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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303 devices foundsorted by relevance

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

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SAA Test Kit FIA

Hangzhou Aichek Medical Technology Co., Ltd.,China

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
Calcium Reagent Kit

Hangzhou Aichek Medical Technology Co., Ltd.,China

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
Calprotectin/FOB Combo Rapid Test

Hangzhou Aichek Medical Technology Co., Ltd.,China

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

Showing 301-303 of 303

deviCERTS Global Medical Device Regulatory Database

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