Qingdao Hisense Medical Co., Ltd.
Manufacturer and brand owner in Qingdao, Shandong, China. 3 device types, 2 products catalogued.
Qingdao Hisense Medical Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Transducer, Ultrasonic, Diagnostic, System, Imaging, Pulsed Echo, Ultrasonic and 1 other device type. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | QINGDAO HISENSE MEDICAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3040391009 |
| FEI number | 3040391009 |
| DUNS | 509751307 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 青岛海信智能医疗技术有限公司 |
|---|---|
| Unified social credit code | 91370212MAEB00AC43 |
| Source | NMPA UDI database |
Location
| City | Qingdao |
|---|---|
| Province | Shandong |
| Address | No. 399 Songling Road, Laoshan District |
| Postal code | 266100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | HD80EXP, L14-6E, HD72S, HD70T, HD86EXP, HD88 and 107 more | 2025 | 22 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | HD80EXP, L14-6E, HD72S, HD70T, HD86EXP, HD88 and 107 more | 2025 | 37 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | HD80EXP, L14-6E, HD72S, HD70T, HD86EXP, HD88 and 107 more | 2025 | 44 |
Own-Brand Listings
Clearances
No clearance names Qingdao Hisense Medical Co., Ltd. as applicant. 2 are 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 |
|---|---|---|---|---|
| K233841 | 2024-05-16 | IYN | Traditional | Qingdao Hisense Medical Equipment Co., Ltd. |
| K233439 | 2024-02-21 | IYN | Traditional | Qingdao Hisense Medical Equipment Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | Color doppler ultrasound, Endoscope monitors, Medical displays, Computer Assisted Surgery System, Digital operating room systems |
| Certifications | ISO 13485, CE, FDA, National Science and Technology Progress Award (Second Class) |
| Export markets | Europe, South Africa, United States, China, Japan |
Nearby Manufacturers
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.