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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 1 of 11

Device	Model / Reference	Registries	Class	Status
Hs60	USS-HS6NL40/WW	FDA UDI	Class II	Active
RS80A Diagnostic Ultrasound System	USS-RS8AF4U/US	FDA UDI	Class II	Active
SonoSync	USO-SYCPK10/SW	FDA UDI	Class II	Active
Ecg/Ahainthesys	USO-UG6EAD0/WR	FDA UDI	Class II	Active
L3-12a	USP-RL03CF5BWR	FDA UDI	Class II	Active
Ugeo H70c Diagnostic Ultrasound System	USS-H70CF10/US	FDA UDI	Class II	Active
Hs60	USS-HS6PF40/WR	FDA UDI	Class II	Active
EKO7 Diagnostic Ultrasound System	USS-EKO7N3C/WW	FDA UDI	Class II	Active
HS40 Diagnostic Ultrasound System	USS-HS4NB3D/US	FDA UDI	Class II	Active
RS80 EVO Diagnostic Ultrasound System	USS-RS8EF40/WW	FDA UDI	Class II	Active
Converting Box	USO-EP6CS10/WR	FDA UDI	Class II	Active
Hs40	USS-HS4NF3E/US	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS6PF40/US	FDA UDI	Class II	Active
E-Motion Marker	USO-UG6EM00/WR	FDA UDI	Class II	Active
S-Tracking Hw	USO-UR8TU00/WR	FDA UDI	Class II	Active
HM70 EVO Diagnostic Ultrasound System	USS-M7EPFCC/US	FDA UDI	Class II	Active
HS70A Diagnostic Ultrasound System	USS-HS7AF3N/US	FDA UDI	Class II	Active
Transducer P3-8	USP-PZ38NAA/WR	FDA UDI	Class II	Active
Transducer CA1-7A	USP-C017FSB/WR	FDA UDI	Class II	Active
Transducer LV3-14A	USP-V03EF0A/WR	FDA UDI	Class II	Active
Transducer C2-8	USP-C028G0A/WR	FDA UDI	Class II	Active
Hm70 Evo	USS-M7ENL10/US	FDA UDI	Class II	Active
HS30 Diagnostic Ultrasound System	USS-HS3PC3B/US	FDA UDI	Class II	Active
Sonoace R3 Cart	USO-CR3CN01/WR	FDA UDI	Class II	Active
RS85 Diagnostic Ultrasound System	USS-RS85E4S/US	FDA UDI	Class II	Active
HS50 Diagnostic Ultrasound System	USS-HS5FN3N/US	FDA UDI	Class II	Active
Hm70 Evo	USS-M7ENC10/US	FDA UDI	Class II	Active
Hm70 Evo	USS-M7ENLCB/US	FDA UDI	Class II	Active
Ecg-Iec	USO-UR8EC00/WR	FDA UDI	Class II	Active
HS30 Diagnostic Ultrasound System	USS-HS3PF2B/US	FDA UDI	Class II	Active
HERA W10 Diagnostic Ultrasound System	USS-HRW1F40/US	FDA UDI	Class II	Active
Hm70 Evo	USS-M7EPFCB/US	FDA UDI	Class II	Active
Accessory Set	USO-YA3ANN0/WR	FDA UDI	Class II	Active
Hera Z20	USS-HZ2N0F04/US	FDA UDI	Class II	Active
HS50 / HS60 Diagnostic Ultrasound System	USS-HS5PF4M/US	FDA UDI	Class II	Active
Sonoace R7 Diagnostic Ultrasound System	USS-SAR7C3K/US	FDA UDI	Class II	Active
Sony Up-X898md	USO-P0NBNH0/WR	FDA UDI	Class II	Active
Ecg/Iecinthesys	USO-UG6EID0/WR	FDA UDI	Class II	Active
Transducer EVN4-9	USP-GN49E0A/WR	FDA UDI	Class II	Active
HERA I10 Diagnostic Ultrasound System	USS-HRI1F40/US	FDA UDI	Class II	Active
Gelwarmer	USO-US7GW00/WR	FDA UDI	Class II	Active
cV4 Diagnostic Ultrasound System	cV4	FDA UDI	Class II	Active
Transducer L5-12/50	USP-LZ5CE5A/WR	FDA UDI	Class II	Active
Ecg-Aha	USO-UR8EA00/WR	FDA UDI	Class II	Active
HM70A Diagnostic Ultrasound System	USS-HM7AF1U/US	FDA UDI	Class II	Active
HS40 Diagnostic Ultrasound System	USS-HS4PB3C/US	FDA UDI	Class II	Active
HERA W9 Diagnostic Ultrasound System	USS-HRW9F3C/US	FDA UDI	Class II	Active
Transducer E3-12A	USP-E03CF0A/WR	FDA UDI	Class II	Active
Transducer C2-6IC	USP-CZ26NSB/WR	FDA UDI	Class II	Active
Lm4-15b	USP-L04FFXB/WR	FDA UDI	Class II	Active

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FDA Establishments (1)

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