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GE ULTRASOUND KOREA, LTD.

South Korea·KR-MF-000001860

Last updated September 17, 2026

Information

Country: South Korea
Address: 9, Sunhwan-ro 214beon-gil, Jungwon-gu,, Seongnam-si, Gyeonggi-do, South Korea
Website: gehealthcare.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jiyeon Park
EUDAMED SRN: KR-MF-000001860
FDA FEI Number: 3003208270
DUNS Number: —

Catalogue (101)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Logiq	S7 R3	FDA UDI	Class II	Active
Logiq	P9 R1 to R2 UPG	FDA UDI	Class II	Active
Voluson	S8 BT18	FDA UDI	Class II	Active
Logiq	P9 R2	FDA UDI	Class II	Active
Voluson	P8 BT16	FDA UDI	Class II	Active
Voluson Signature 18	Voluson Signature 18 BT27 / 5994025	EUDAMED	Class IIa	Active
Logiq P8, Logiq P9, Logiq P10	LP9 R4 to R4.5 SW Conversion/H43012LF	EUDAMEDFDA UDI	Class IIa	Active
Voluson Signature 20	Voluson Signature 20 / 5926010	EUDAMEDFDA UDI	Class IIa	Active
Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S6	Voluson Signature to BT22 UPG / 5881172	EUDAMEDFDA UDI	Class IIa	Active
Voluson SWIFT to BT23 UPG	H43222LN	EUDAMEDFDA UDI	Class IIa	Active
Logiq P8, Logiq P9, Logiq P10	LOGIQ P10 R4.5/H42932LD	EUDAMEDFDA UDI	Class IIa	Active
Voluson Signature 20	Voluson Signature 20 BT27 / 5993975	EUDAMED	Class IIa	Active
LOGIQ Fortis	LOGIQ Fortis R4 HDU / 6602000-10	EUDAMEDFDA UDI	Class IIa	Active
Logiq P8, Logiq P9, Logiq P10	LOGIQ P9 R4.5/H42932LC	EUDAMEDFDA UDI	Class IIa	Active
Voluson S6	Voluson S6 BT22 / 5882276	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ Totus, LOGIQ Totus HDU	LOGIQ Totus R5 HDU / 9685091	EUDAMED	Class IIa	Active
Voluson S10	Voluson S10 BT22 / 5880998	EUDAMEDFDA UDI	Class IIa	Active
Voluson P8, Voluson P6	Voluson Performance to BT22 UPG / 5881175	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ Totus, LOGIQ Totus HDU	LOGIQ Totus/H46202LA	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ Totus, LOGIQ Totus HDU	LOGIQ Totus R5 SW upgrade / 9687264	EUDAMED	Class IIa	Active
Voluson P8, Voluson P6	Voluson P6 BT22 / 5882279	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ E10s	5874356	EUDAMEDFDA UDI	Class IIa	Active
Logiq P8, Logiq P9, Logiq P10	LOGIQ P10 R4.5 HD/H42932LE	EUDAMEDFDA UDI	Class IIa	Active
Voluson Performance 18	Voluson Performance 18 / 5957172	EUDAMEDFDA UDI	Class IIa	Active
Voluson Performance 16	Voluson Performance 16 / 5957171	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ E10s	LOGIQ E10s R2R3 to R4 HW Upgrade W / 5946724	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ E10s	LOGIQ E10s R2R3 to R4 SW Upgrade / 5946721	EUDAMEDFDA UDI	Class IIa	Active
Logiq P8, Logiq P9, Logiq P10	LP10 R4 to R4.5 SW Conversion/H43012LG	EUDAMEDFDA UDI	Class IIa	Active
Logiq P8, Logiq P9, Logiq P10	LOGIQ P8 R4.5/H42932LB	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ E10s	LOGIQ E10s R4 to R5 UPG / 5973865	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ Totus, LOGIQ Totus HDU	LOGIQ Totus HDU/TBD	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ Fortis	6602000	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ E10s	LOGIQ E10s R3R4_R5 UPG HW / 5946722-5	EUDAMED	Class IIa	Active
LOGIQ Fortis	LOGIQ Fortis R4 LCD / 6601000-10	EUDAMEDFDA UDI	Class IIa	Active
Voluson S8	Voluson S8 BT22 / 5881046	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ E10s	LOGIQ E10s R3R4_R5 UPG HW Wireless / 5946724-5	EUDAMED	Class IIa	Active
LOGIQ Fortis	LOGIQ Fortis R3 to R4 SW Upgrade / 5946725	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ E10s	LOGIQ E10s R4 / 5921403	EUDAMEDFDA UDI	Class IIa	Active
Voluson Signature 18	Voluson Signature 18 / 5928500	EUDAMEDFDA UDI	Class IIa	Active
Voluson SWIFT	H43222LS / H43222LR / H43222LN	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ Fortis	LOGIQ Fortis R3 to R4 HW Upgrade W / 5946728	EUDAMEDFDA UDI	Class IIa	Active
Voluson P8, Voluson P6	Voluson P8 BT22 / 5882489	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ Fortis	LOGIQ Fortis R3-R5 SW & WiFi Upgrade / 5946727-5	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ E10s	LOGIQ E10s R2 to R3 UPG / 5874847	EUDAMEDFDA UDI	Class IIa	Active
Logiq P8, Logiq P9, Logiq P10	LP8 R4 to R4.5 SW Conversion/H43012LE	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ E10s	5860223	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ E10s	LOGIQ E10s R3R4_R5 UPG / 5946721-5	EUDAMEDFDA UDI	Class IIa	Active
Voluson S10 Expert	Voluson S10 Expert BT22 / 5880987	EUDAMEDFDA UDI	Class IIa	Active
Voluson SWIFT+	H43222LR	EUDAMEDFDA UDI	Class IIa	Active
LOGIQ Fortis	LOGIQ Fortis R3-R5 SW & HW Upgrade / 5946726-5	EUDAMED	Class IIa	Active

GE ULTRASOUND KOREA, LTD.

Information

Catalogue (101)

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