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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 6 Class IIa Class IIb Class III Class II (US) 15

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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: Gamma Enterprises, Inc.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

Total Bilirubin

Gamma Enterprises, Inc.,United States(FDA applicant)

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

Gamma Enterprises, Inc.,United States(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:I
Albumin

Gamma Enterprises, 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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