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Registry EUDAMED FDA 510(k) incl. De Novo 6 FDA PMA GUDID 17

Country / market United States 23

Risk class Class I Class IIa Class IIb Class III Class II (US) 22

More classes (11)

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) 1 Not classified (FDA)

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23 devices foundsorted by relevance

Manufacturer: Incore Co., Ltd.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

CORE-Trocar

Incore Co., Ltd.,South Korea(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:II
Hemoblock_S (Prescription); Hemoblock_S (OTC)

Incore Co., Ltd.,South Korea(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:—
Core-Injector

Incore Co., Ltd.,South Korea(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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