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SAMSUNG MEDISON CO., LTD

South Korea·KR-MF-000011620

Last updated September 17, 2026

Information

Country: South Korea
Address: 3366, Hanseo-ro, Gangwon-do, South Korea
Website: samsung.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82 2 2194 0897
PRRC Contact: Hyeonho Kim
EUDAMED SRN: KR-MF-000011620
FDA FEI Number: 3010289997
DUNS Number: 687785691

Catalogue (542)

Page 2 of 11

Device	Model / Reference	Registries	Class	Status
HERA W9, HERA W10 Diagnostic Ultrasound System	USS-HRW9F4D/US	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS5PB4K/US	FDA UDI	Class II	Active
HERA W10 Diagnostic Ultrasound System	USS-HRW1F40/WW	FDA UDI	Class II	Active
Transducer 3DC2-6	USP-V026E0C/WR	FDA UDI	Class II	Active
HS60 Diagnostic Ultrasound System	USS-HS6NB4N/US	FDA UDI	Class II	Active
Clear Track Package	USO-UR8CFA0/WR	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS5NB3K/US	FDA UDI	Class II	Active
Transducer L5-12/60	USP-LZ5CEDB/WR	FDA UDI	Class II	Active
Rs85	USS-RS85G4I/US	FDA UDI	Class II	Active
Transducer PE2-4	USP-PE24F0A/WR	FDA UDI	Class II	Active
H60 Diagnostic Ultrasound System	USS-H60NF4L/WW	FDA UDI	Class II	Active
Hs40	USS-HS4NB4F/US	FDA UDI	Class II	Active
HM70 EVO Diagnostic Ultrasound System	USS-M7ENL1C/US	FDA UDI	Class II	Active
Hs60	USS-HS6NL40/WR	FDA UDI	Class II	Active
Mysono U6 Cart	USO-CU6CN02/WR	FDA UDI	Class II	Active
HS40 Diagnostic Ultrasound System	USS-HS4PB4C/US	FDA UDI	Class II	Active
HS50 Diagnostic Ultrasound System	USS-HS5FB4N/US	FDA UDI	Class II	Active
Transducer L4-7	USP-L047N0A/WR	FDA UDI	Class II	Active
Dynamic MR	USO-U0NDU00/WR	FDA UDI	Class II	Active
Hs60	USS-HS6NL40/ND	FDA UDI	Class II	Active
HERA W9, HERA W10 Diagnostic Ultrasound System	USS-HRW9R3D/US	FDA UDI	Class II	Active
Ca3-10a	USP-C03AF5B/WR	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS6NB4M/US	FDA UDI	Class II	Active
HS30 Diagnostic Ultrasound System	USS-HS3PF20/US	FDA UDI	Class II	Active
Ca1-7a	USP-RC017FSBWR	FDA UDI	Class II	Active
HERA W9 Diagnostic Ultrasound System	USS-HRW9F40/US	FDA UDI	Class II	Active
Ecg	USO-US7EA00/WR	FDA UDI	Class II	Active
Transducer CA2-8AD	USP-CE28F7A/WR	FDA UDI	Class II	Active
Transducer PE2-4	USP-PZ24NAA/WR	FDA UDI	Class II	Active
Transducer LA3-16A	USP-L03GF4B/WR	FDA UDI	Class II	Active
HS70A Diagnostic Ultrasound System	USS-HS7NF4N/US	FDA UDI	Class II	Active
Ls3-14b	USP-L03ENNA/WR	FDA UDI	Class II	Active
HS40 Diagnostic Ultrasound System	USS-HS4NL4D/US	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS5PF3K/US	FDA UDI	Class II	Active
Ecg-Iec/D	USO-UR8ECD0/WR	FDA UDI	Class II	Active
Transducer VN4-8	USP-VN48E0A/WR	FDA UDI	Class II	Active
WS80A Diagnostic Ultrasound System	USS-WS8AL4K/US	FDA UDI	Class II	Active
Hs40	USS-HS4PB4F/US	FDA UDI	Class II	Active
Ca1-7a	USP-C017FSD/WR	FDA UDI	Class II	Active
HERA W9 Diagnostic Ultrasound System	USS-HRW9R4E/US	FDA UDI	Class II	Active
Hs40	USS-HS4NL4F/US	FDA UDI	Class II	Active
HM70 EVO Diagnostic Ultrasound System	USS-M7ENFCC/US	FDA UDI	Class II	Active
HS40 Diagnostic Ultrasound System	USS-HS4PF3B/US	FDA UDI	Class II	Active
5d Heart Color	USO-UW85HP0/WR	FDA UDI	Class II	Active
HM70A Diagnostic Ultrasound System	USS-HM7AF1K/US	FDA UDI	Class II	Active
S-Fusion Package	USO-UR8FPD0/WR	FDA UDI	Class II	Active
Transducer LA4-18B	USP-L04IF4A/WR	FDA UDI	Class II	Active
Evn4-9	USP-GN49N0B/WR	FDA UDI	Class II	Active
Advr2	USO-U0NAU0K/WR	FDA UDI	Class II	Active
Cleartrack Package	USO-UR8CIC0/WR	FDA UDI	Class II	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Samsung Medison Co., Ltd. Gumi-si Gyeongbuk · KR FEI 3009758186