Shenzhen Urion Technology Co., Ltd.
Shenzhen Guangdong, CN
SHENZHEN URION TECHNOLOGY CO., LTD. appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Shenzhen Urion Technology Co., Ltd. between 2015 and 2026. The busiest year on record is 2025, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | DXN | Substantially Equivalent | |
| 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 | |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | IRP | Substantially Equivalent | |
| 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 | |
| K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | DXN | Substantially Equivalent | |
| K200802 | Infrared Thermometer | FLL | Substantially Equivalent | |
| K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K141683 | ELECTRONIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011654863 | 3011654863 | SHENZHEN URION TECHNOLOGY CO., LTD. | Floor 4th-6th of Building D , Jiale Science&Technology Industrial Zone, No.3 , ChuangWei Road ,Heshuikou, Shenzhen Guangdong 518106 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QTCAdult Portable Bed Rails For Medical Purposes
- FLLContinuous Measurement Thermometer
- ILYLamp, Infrared, Therapeutic Heating
- IRPMassager, Powered Inflatable Tube
- ISAMassager, Therapeutic, Electric
- JPWPump, Nebulizer, Electrically Powered
- INFScale, Platform, Wheelchair
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- JEQToothbrush, Powered
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain