Shenzhen Urion Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 5 device types, 204 products catalogued, 8 clearances.
Shenzhen Urion Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Toothbrush, Powered, Massager, Powered Inflatable Tube and 3 other device types. 204 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | SHENZHEN URION TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011654863 |
| FEI number | 3011654863 |
| DUNS | 421294358 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市优瑞恩科技有限公司 |
|---|---|
| Unified social credit code | 91440300571971732H |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Floor 4th-6th of Building D , Jiale Science&Technology Industrial Zone, No.3 , ChuangWei Road ,Heshuikou |
| Postal code | 518106 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Continuous Measurement Thermometer | Class 2 | Infrared Thermometer TP-336, Infrared Thermometer UFR102, Infrared Thermometer UFR103,UFR116,UFR205,UFR105,UFR201, Andesfit Ltd Infrared Thermometer ADF-B33A | 2020 | 115 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Red Light Support Belt RL 450, RL 450G, RL 450B, RL 600, RL 600G, RL 600B, G78B, G15, Red Light Belt RL 500, RL 500B, RL 500G, RL 550, RL 550B, RL 550G, G78 | 2024 | 235 |
| Massager, Powered Inflatable Tube | Class 2 | Air Compression Leg Massager (UM605,UM606, UM607,UM608,UM609,UM610,UM611,UM617) | 2025 | 37 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Andesfit Ltd ADF-B180, Upper Arm Electronic Blood Pressure Monitor U85E, U86E, TelliBP01, U80D, U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH), U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z), Upper Arm Electronic Blood Pressure Monitor U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH) and 21 more | 2015 | 98 |
| Toothbrush, Powered | Class 1 | Electric Toothbrush S1, S1 MAX | 2026 | 191 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K254048 | 2026-05-14 | DXN | Traditional | This company |
| K260273 | 2026-03-26 | DXN | Traditional | This company |
| K250046 | 2025-04-25 | IRP | Traditional | This company |
| K243115 | 2025-02-21 | DXN | Traditional | This company |
| K241007 | 2024-10-24 | DXN | Traditional | This company |
| K200802 | 2020-10-07 | FLL | Traditional | This company |
| K160019 | 2016-04-22 | DXN | Traditional | This company |
| K141683 | 2015-04-03 | DXN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Main products | blood pressure monitors, thermometers, nebulizers, massage devices, beauty devices |
| Certifications | CE, FDA, CFDA, BSCI |
| Export markets | 100+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.