FDA Device Establishments · JSON-LD · Markdown

GE ULTRASOUND KOREA, LTD.

FEI 3003208270 · Manufacture Medical Device · Status: Active

FEI Number3003208270
Owner / OperatorGE HealthCare Technologies Inc. (#9912004)
Address9, Sunhwan-ro 214beon-gil, J, ungwon-gu, Gyeonggi-do, Seongnam-Si Gyeonggi, 13204, KR
Mandatory US AgentGE HealthCare Technologies, Inc
Registration expiry2026
Initial importer flagN
Registered products3
Product codes (top 20)ITX, IYO, IYN
Regulation § (21 CFR)892.1570, 892.1560, 892.1550
Proprietary namesVoluson S10; Voluson S series BT16; Voluson S series; E8C-RS; ML6-15-RS; C1-5-RS; RAB6-RS; Voluson S6; 3Sc-RS; Voluson S10 BT16

External sources

Source: openFDA. Public-domain (CC0).