Data / Medical devices / China / Qingdao Hisense Medical Co., Ltd.
Qingdao Hisense Medical Co., Ltd.: FDA-registered device maker in Qingdao Shandong, China, 2 510(k) clearances
Qingdao Hisense Medical Co., Ltd. is registered with the FDA (registration 3040391009) in Qingdao Shandong, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 16, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3040391009
- Address
- No. 399 Songling Road, Laoshan District, Qingdao Shandong, China, 266100
- Owner or operator
- Qingdao Hisense Medical Co., Ltd. (10093827)
- Roles
- Manufacturer
- First device listed
- August 22, 2025
- Registered through
- 2026
- Brand names listed
- C5-1E, C5-2A, C5-2L, DC6-2A, DC7-2A, DC7-2E, DE10-3E, E9-3E and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 16, 2024 | K233841 | HD80 Series Ultrasound Diagnostic System | IYN | Substantially Equivalent | Qingdao Hisense Medical Equipment Co., Ltd. | accessdata.fda.gov |
| February 21, 2024 | K233439 | HD60 Series Ultrasound Diagnostic System | IYN | Substantially Equivalent | Qingdao Hisense Medical Equipment Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated May 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.