Data / Medical devices / China / Shenzhen Urion Technology Co., Ltd.
Shenzhen Urion Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 8 510(k) clearances
Shenzhen Urion Technology Co., Ltd. is registered with the FDA (registration 3011654863) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 14, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011654863
- Address
- Floor 4th-6th of Building D, Jiale Science&Technology Industrial Zone, No.3, ChuangWei Road,Heshuikou Community,MaTian St.,GuangMing New District, Shenzhen Guangdong, China, 518106
- Owner or operator
- Shenzhen Urion Technology Co., Ltd. (10049394)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 25, 2015
- Registered through
- 2027
- Brand names listed
- Air Compression Leg Massager (UM605,UM606, UM607,UM608,UM609,UM610,UM611,UM617), Andesfit Ltd ADF-B103W, Andesfit Ltd ADF-B180, Andesfit Ltd Infrared Thermometer ADF-B33A, Automatic Electronic Blood Pressure Monitor U90B, U90B Pro, U90B Plus, U90B Ultra, Automatic Electronic Blood Pressure Monitor U90C, U90C Pro, U90C Plus, U90C Ultra, BU A55,BU A57,BU 510,BU 512,BU 514,BU 516, Infrared Thermometer TP-336 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| May 14, 2026 | K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| March 26, 2026 | K260273 | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| April 25, 2025 | K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | IRP | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| February 21, 2025 | K243115 | Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| October 24, 2024 | K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| October 7, 2020 | K200802 | Infrared Thermometer | FLL | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| April 22, 2016 | K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
| April 3, 2015 | K141683 | ELECTRONIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Continuous Measurement Thermometer
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Massager, Powered Inflatable Tube
Updated May 14, 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.