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Registry EUDAMED FDA 510(k) incl. De Novo 23 FDA PMA GUDID

Country / market United States 23

Risk class Class I 7 Class IIa Class IIb Class III Class II (US) 16

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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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23 devices foundsorted by relevance

Manufacturer: Sandare Chemical Co., Inc.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

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Sandare Alkaline Phosphatase Procedure

Sandare Chemical Co., Inc.,United States(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:II
Sandare Iron Procedure

Sandare Chemical Co., Inc.,United States(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:I
Sandare Cyanmethemoglobin Reagent

Sandare Chemical Co., Inc.,United States(FDA applicant)

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

Showing 21-23 of 23

deviCERTS Global Medical Device Regulatory Database

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