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Sign in to claim this brandSamsung Electronics Co.,Ltd
South Korea·KR-MF-000020682
Last updated September 18, 2026
About
Samsung Healthcare offers comprehensive medical imaging solutions and equipment including ultrasound machines, X-ray systems, and CT scanners. Stay updated with our latest innovations showcased at medical congresses and access educational resources for ultrasound applications.
From the manufacturer's own website. Source
Information
- Country
- South Korea
- Address
- 129, Samsung-ro, Suwon-si, South Korea
- Website
- www.samsunghealthcare.com
- —
- [email protected]
- Phone
- +82-1588-3366
- PRRC Contact
- SANGHYUN HWANG
- EUDAMED SRN
- KR-MF-000020682
- FDA FEI Number
- 3032116890
- DUNS Number
- —
Catalogue (41)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Xgeo Gc80 | K140334 | FDA 510(k) | Class II | Active |
| Digital Diagnostic Mobile X-ray System | K181626 | FDA 510(k) | Class II | Active |
| ECG Monitor App | K201168 | FDA 510(k) | Class II | Active |
| Xgeo Gu60 | K123105 | FDA 510(k) | Class II | Active |
| Gf50a | K151419 | FDA 510(k) | Class II | Active |
| Gm85 | K171119 | FDA 510(k) | Class II | Active |
| S Health | K132148 | FDA 510(k) | Class II | Active |
| Gm85 | K242651 | FDA 510(k) | Class II | Active |
| Xgeo Gf50 | K140326 | FDA 510(k) | Class II | Active |
| Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | K230292 | FDA 510(k) | Class II | Active |
| Xgeo Gr40cw | K140235 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Xgeo Gc80 | K123098 | FDA 510(k) | Class II | Active |
| GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | K180543 | FDA 510(k) | Class II | Active |
| Gu60a & Gu60a-65 | K173828 | FDA 510(k) | Class II | Active |
| Gc70, Gu60a, Gu60a-65, Gf50, Gr50a ; Gr40cw ; Gm85 ; Gc85a | K182183 | FDA 510(k) | Class II | Active |
| Digital Diagnostic Mobile X-ray System | K162278 | FDA 510(k) | Class II | Active |
| Xgeo Gu60a | K140332 | FDA 510(k) | Class II | Active |
| Gua60a, Gu60a-65 | K151685 | FDA 510(k) | Class II | Active |
| Gc70 | K163115 | FDA 510(k) | Class II | Active |
| GF85 (models GF85-3P, GF85-SP) | K242478 | FDA 510(k) | Class II | Active |
| Digital Diagnostic X-ray System (GC80) | K143029 | FDA 510(k) | Class II | Active |
| Gu60a, Gu60a-65 | K182622 | FDA 510(k) | Class II | Active |
| Gm60a-32s, Gm60a-40s | K142492 | FDA 510(k) | Class II | Active |
| Gm60a-32s & Gm60a-40s | K150097 | FDA 510(k) | Class II | Active |
| CUBE Air Purifier | K211139 | FDA 510(k) | Class II | Active |
| Gm85 | K222353 | FDA 510(k) | Class II | Active |
| Gems-H | K213452 | FDA 510(k) | Class II | Active |
| Digital Diagnostic X-Ray System Model Xgeo Gu60a | K123106 | FDA 510(k) | Class II | Active |
| Gc70 | K182647 | FDA 510(k) | Class II | Active |
| Gm85 | K220175 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Gf85-3p | GF85-3P | EUDAMEDFDA UDI | Class IIb | Active |
| ECG App | v1.3 | EUDAMEDFDA UDI | Class IIa | Active |
| Gc85a | GC85A | EUDAMEDFDA UDI | Class IIb | Active |
| Gf85-Sp | GF85-SP | EUDAMEDFDA UDI | Class IIb | Active |
| Sleep Apnea Feature | v 1.0 | EUDAMEDFDA UDI | Class IIa | Active |
| ECG App | 360049 | EUDAMEDFDA UDI | Class IIa | Active |
| Gr40cwd | GR40CWD | EUDAMEDFDA UDI | Class IIa | Active |
| Blood Pressure App | v1.1 | EUDAMED | Class IIa | Active |
| Auto Lung Nodule Detection | Auto Lung Nodule Detection | EUDAMED | Class IIa | Active |
| Sleep Apnea Feature | v 1.0 | EUDAMEDFDA UDI | Class IIa | Active |
| ECG App | 360049 | EUDAMEDFDA UDI | Class IIa | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Samsung Electronics Co., Ltd. US