Data / Medical devices / China / Shenzhen Hingmed Medical Instrument Co., Ltd
Shenzhen Hingmed Medical Instrument Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Shenzhen Hingmed Medical Instrument Co., Ltd is registered with the FDA (registration 3043047278) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 13, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3043047278
- Address
- 4th Floor, Zhonghangfeixiang Building, NO. 371 Guangshen Road, Baoan District, Shenzhen, China, Shenzhen Guangdong, China, 518102
- Owner or operator
- Shenzhen Hingmed Medical Instrument Co., Ltd (10095417)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 11, 2026
- Registered through
- 2027
- Brand names listed
- Clinical Automatic Blood Pressure Monitor (DBP-01P, DBP-01HP), Clinical Automatic Blood Pressure Monitor (DBP-20, DBP-20i), Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| February 13, 2026 | K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | DXN | Substantially Equivalent | Shenzhen Hingmed Medical Instrument Co., Ltd. | accessdata.fda.gov |
| January 12, 2026 | K251307 | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | DXN | Substantially Equivalent | Shenzhen Hingmed Medical Instrument Co., Ltd. | accessdata.fda.gov |
| March 26, 2024 | K231984 | Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) | DXN | Substantially Equivalent | Shenzhen Hingmed Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 13, 2026. 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.