Data / Medical devices / China / Shenzhen Hanhan Technology Co., Ltd
Shenzhen Hanhan Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Hanhan Technology Co., Ltd is registered with the FDA (registration 3045076243) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 1, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045076243
- Address
- Building B1,b301,Yingzhan Technology Park,No.8 Longtian Tongfuyu Road, Longtian Community, Longtian Street Pingshan District, Shenzhen Guangdong, China, 518118
- Owner or operator
- Shenzhen HanHan Technology Co., Ltd (10095765)
- Roles
- Manufacturer
- First device listed
- April 26, 2026
- Registered through
- 2026
- Brand names listed
- Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL, BP-510, HH-BP04C), HH-808EL Arm Blood Pressure Monitor, HH-B03E Arm Blood Pressure Monitor, HH-B04C Arm Blood Pressure Monitor, HH-B04E Arm Blood Pressure Monitor, HH-B09C Arm Blood Pressure Monitor, HH-BP01 Arm Blood Pressure Monitor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 |
|---|---|---|---|---|---|---|
| April 1, 2026 | K254225 | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | DXN | Substantially Equivalent | Shenzhen HanHan Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 1, 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.