Eieling Technology (Shenzhen) Limited
Registered establishment in Nanshan District, Shenzhen, Guangdong, China. 2 device types, 2 clearances.
Eieling Technology (Shenzhen) Limited is a manufacturer holding a current FDA establishment registration. The registration covers Transducer, Ultrasonic, Diagnostic, System, Imaging, Pulsed Echo, Ultrasonic. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | EIELING TECHNOLOGY (SHENZHEN) LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3033743848 |
| FEI number | 3033743848 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 意领科技（深圳）有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Nanshan District, Shenzhen |
|---|---|
| Province | Guangdong |
| Address | RM610, Building E, Qihang Innovation Development Park, No. 1008 Songbai Road,Yangguang Community, Xili Street |
| Postal code | 518055 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C), The FattaLab, Liver fat ultrasound quantitative system, Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | 2024 | 37 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C), The FattaLab, Liver fat ultrasound quantitative system, Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | 2024 | 44 |
Clearances
2 clearances name Eieling Technology (Shenzhen) Limited as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253221 | 2026-02-06 | IYO | Traditional | This company |
| K242496 | 2024-11-19 | IYO | Traditional | This company |
| K233401 | 2024-02-12 | IYO | Traditional | Eieling Technology Limited |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2018 |
|---|---|
| Main products | Liverscan liver elastography, FattaLab liver fat quantification, Wireless ultrasound probes, AI diagnostic software, Point-of-care liver monitoring |
| Certifications | ISO 13485, FDA, NMPA, TFDA, MOH, BPOM, MDA, EDA |
| Export markets | Mainland China, Hong Kong, Southeast Asia, North America, South America, Middle East, Africa |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.