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Sign in to claim this brandGE ULTRASOUND KOREA, LTD.
South Korea·KR-MF-000001860
Last updated September 17, 2026
What GE ULTRASOUND KOREA, LTD. makes
The company manufactures ultrasound imaging systems, including the Voluson Signature series (models BT27 UPG, 18, 20, S10 Expert, S10, S8t, S8, S6, and SWIFT BT23 UPG) and the LOGIQ series (models P8, P9, P10, Fortis, and Totus, including the Totus HDU). These devices are designed for obstetrics, gynecology, and general diagnostic imaging, supporting real-time visualization and diagnostic assessments.
The portfolio consists of Class IIa medical devices, all of which are registered in the EU’s eudamed database. The company is based in Korea.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does GE ULTRASOUND KOREA, LTD. manufacture?
GE ULTRASOUND KOREA, LTD. specializes in ultrasound imaging systems, including the Voluson Signature series (such as the Voluson Signature to BT27 UPG, Voluson S10 Expert, and Voluson S6) and the LOGIQ series (like the LOGIQ P8, LOGIQ Fortis, and LOGIQ Totus HDU). These devices are primarily used for obstetrics, gynecology, and general diagnostic imaging, enabling real-time visualization and diagnostic evaluations.
Where is GE ULTRASOUND KOREA, LTD. based?
The company is headquartered in Korea, where it develops and manufactures its ultrasound imaging systems. This geographic location influences its regulatory compliance and market focus, particularly in Asia and global markets where its devices are distributed.
Which regulatory registries list the devices manufactured by GE ULTRASOUND KOREA, LTD.?
The devices produced by GE ULTRASOUND KOREA, LTD. are registered in the EU’s eudamed database, which is the official European Union registry for medical devices. This registration is required for Class IIa devices to demonstrate compliance with EU regulations and ensure traceability.
How are the devices manufactured by GE ULTRASOUND KOREA, LTD. classified under medical device regulations?
All devices produced by GE ULTRASOUND KOREA, LTD. fall under the classification of Class IIa medical devices. This classification is determined based on their intended use and risk level, requiring compliance with specific regulatory controls to ensure safety and performance, such as clinical evaluations and conformity assessments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- South Korea
- Address
- 9, Sunhwan-ro 214beon-gil, Jungwon-gu,, Seongnam-si, Gyeonggi-do, South Korea
- Website
- gehealthcare.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Jiyeon Park
- EUDAMED SRN
- KR-MF-000001860
- FDA FEI Number
- 3003208270
- DUNS Number
- —
Catalogue (111)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LOGIQ E10s | LOGIQ E10s Special Upgrade Kit / 5951946 | EUDAMED | Class IIa | Active |
| LOGIQ E10s | LOGIQ E10s R3 Am / 5860223-20 | EUDAMED | Class IIa | Active |
| Voluson Signature to BT27 UPG | Voluson Signature to BT27 UPG / 6009766 | EUDAMED | Class IIa | Active |
| Logiq | S8 R4 to R4.5 UPG | FDA UDI | Class II | Active |
| Logiq | S8 | FDA UDI | Class II | Active |
| Logiq | P9 R3 to R4 UPG | FDA UDI | Class II | Active |
| Logiq | S8 R4 OLED | FDA UDI | Class II | Active |
| Logiq | E10s | FDA UDI | Class II | Unknown |
| Logiq | P10 R4 | FDA UDI | Class II | Active |
| Logiq | S8 R4 | FDA UDI | Class II | Active |
| Logiq | S8 R3 OLED | FDA UDI | Class II | Active |
| Logiq | P7 R2_2.5 to R3 UPG | FDA UDI | Class II | Active |
| Voluson | S6 BT12 to BT14 UPG | FDA UDI | Class II | Active |
| Logiq | P9 R4 | FDA UDI | Class II | Active |
| Voluson | S6 BT14 to BT15 UPG | FDA UDI | Class II | Active |
| Voluson | P8 BT13 to BT14 UPG | FDA UDI | Class II | Active |
| Logiq | P9 R2.5 | FDA UDI | Class II | Active |
| Voluson | S8t BT18 | FDA UDI | Class II | Active |
| Logiq | S8 R4 LCD | FDA UDI | Class II | Active |
| Voluson | S10 BT18 | FDA UDI | Class II | Active |
| Logiq | S8 R1 to R2 UPG | FDA UDI | Class II | Active |
| Logiq | P9 R2 to R2.5 UPG | FDA UDI | Class II | Active |
| Voluson | SWIFT | FDA UDI | Class II | Active |
| Voluson | P8 BT18 | FDA UDI | Class II | Active |
| Logiq | P9 R2.5 to R3 UPG | FDA UDI | Class II | Active |
| Logiq | S8 R3 to R4 UPG | FDA UDI | Class II | Active |
| Logiq | P7 R2.5 to R3 UPG | FDA UDI | Class II | Active |
| Logiq | S7 R1 to R2 UPG | FDA UDI | Class II | Active |
| Logiq | E10s R2R3 to R4 HW Upgrade | EUDAMEDFDA UDI | Class II | Active |
| Voluson | S8 Pro BT16 | FDA UDI | Class II | Active |
| Voluson | P6 BT16 | FDA UDI | Class II | Active |
| Logiq | P9 R3 | FDA UDI | Class II | Active |
| Logiq | P9 R2_2.5 to R3 UPG | FDA UDI | Class II | Active |
| Voluson | S8 BT11 to BT12 UPG | FDA UDI | Class II | Active |
| Voluson | SWIFT+ | FDA UDI | Class II | Active |
| Voluson | S6 BT11 to BT12 UPG | FDA UDI | Class II | Active |
| Voluson | S8 BT14 to BT15 UPG | FDA UDI | Class II | Active |
| Voluson | S8 BT12 to BT14 UPG | FDA UDI | Class II | Active |
| Logiq | P7 R2.5 | FDA UDI | Class II | Active |
| Logiq | P8 R4 | FDA UDI | Class II | Active |
| Logiq | E10s R2R3 to R4 SW Upgrade W | EUDAMEDFDA UDI | Class II | Active |
| Voluson | S10 Expert BT18 | FDA UDI | Class II | Active |
| Logiq | P7 R2 | FDA UDI | Class II | Active |
| Voluson | S10 BT16 | FDA UDI | Class II | Active |
| Voluson | P8 BT14 to BT15 UPG | FDA UDI | Class II | Active |
| Voluson | S8 BT16 | FDA UDI | Class II | Active |
| Logiq | P9 | FDA UDI | Class II | Active |
| Logiq | S8 R1R2 to R3 UPG | FDA UDI | Class II | Active |
| Logiq | S7 R2 to R3 UPG | FDA UDI | Class II | Active |
| Logiq | P9 R1 to R2 UPG | FDA UDI | Class II | Active |
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