Shenzhen Yuwen E-Commerce Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 19 device types, 11 products catalogued.
Shenzhen Yuwen E-Commerce Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Orthosis, Lumbar, Cushion, Hemorrhoid and 17 other device types. 11 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | SHENZHEN YUWEN E-COMMERCE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013957847 |
| FEI number | 3013957847 |
| DUNS | 544559614 |
| Establishment type | Repacker / relabeller, Private-label distributor, Exporter |
Chinese Registration
| Chinese legal name | 深圳誉文电子商务有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 703 Room,7F, No.153, Zhonghuicai Building |
| Postal code | 518109 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adult Portable Bed Rails For Medical Purposes | Class 1 | AUVON, Bedrails, model MB1121 | 2024 | 40 |
| Component, Traction, Non-Invasive | Class 1 | AUVON, Inflatable Neck Stretcher, model NI3663 | 2026 | 18 |
| Cushion, Hemorrhoid | Class U | AUVON, Hemorrhoid Cushion, model SH5132, AUVON, Seat Cushion, model SO7732, AUVON, Innovative Donut Pillow, model SH2162, AUVON, Hemorrhoid Cushion, model SH3172, AUVON, Cool Donut Pillow, model SH2632, AUVON, Multi-layer Gel Cushion, model SO7632 | 2024 | 4 |
| Cushion, Wheelchair | Class 1 | AUVON, Cooling Gel Wheelchair Seat Cushion, model SW6652, AUVON, Wheelchair Seat Cushions, model SC1111, AUVON, Anti-Slip Wheelchair Cushions, model SW4111, AUVON, Ventilation Seat Cushion, model SW6412, AUVON Pressure relief wheelchair cushion, model SW6321, AUVON, Gel seat cushion, model SW1651 | 2024 | 53 |
| Dispenser, Solid Medication | Class 1 | AUVON, Pill Organizer, model PD4007, Pill Organizer, AUVON, Pill Organizer, model PO1807, Pill Dispenser, AUVON, Pill Organizer, model PO6008, AUVON, Pill Dispenser, model PD4000 and 5 more | 2018 | 68 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | AUVON, Clear Adhesive Waterproof Hydrogel Dressing, model SAS0410, AUVON, Clear Adhesive Waterproof Hydrogel Dressing, model SAS0403 | 2025 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | AUVON, Silicone Foam Dressing, model SAS0322, AUVON, SILICONE FOAM DRESSING, model SAS0407, SAS0412, SAS0422, AUVON, Silicone Foam Dressing, model SAS0310, AUVON, SACRUM SILICONE FOAM DRESSING, model SAH0705, SAH0710, AUVON, Silicone Foam Dressing, model SAS0603 | 2024 | 195 |
| Electrode, Cutaneous | Class 2 | AUVON, Adhesive Electrodes, model EB1548, AUVON, Adhesive Electrodes, model EB1520, AUVON, Adhesive Electrodes, model EP3M12 | 2019 | 47 |
| Glucose Oxidase, Glucose | Class 2 | AUVON, BLOOD GLUCOSE TEST STRIPS & STERILE LANCETS, model DS-W, AUVON, BLOOD GLUCOSE TEST STRIPS, model DS-W, AUVON, BLOOD GLUCOSE MONITORING SYSTEM, model DS-W | 2018 | 8 |
| Insulin Vial Protector/Holder | Class 1 | AUVON, Insulin Pen Cooler Travel Case, model BO2120, AUVON, Insulin Pen Cooler Travel Case, model BO1120, AUVON, Insulin Pen Cooler Travel Case, model BO1341, AUVON, Insulin Pen Cooler Travel Case, model BO3213, AUVON, Insulin Pen Cooler Travel Case, model BO1221, AUVON, Insulin Pen Cooler Travel Case, model BO3313 | 2025 | 7 |
| Media, Electroconductive | Class 2 | AUVON, Conductive Gel, model CG2252 | 2023 | 8 |
| Multiple Use Blood Lancet For Single Patient Use Only | Class 2 | AUVON,BLOOD GLUCOSE TEST STRIPS & STERILE LANCETS, model DS-W, AUVON, Lancing Device & Twist Lancets, Auvon, Sterile Lancets, AUVON, BLOOD GLUCOSE MONITORING SYSTEM, model DS-W | 2022 | 21 |
| Orthosis, Lumbar | Class 1 | AUVON, lumbar pillow, model WO2121 | 2025 | 110 |
| Pill Crusher/Cutter | Class 1 | AUVON, Pill Splitter, model PS1111 | 2018 | 41 |
| Protector, Skin Pressure | Class 1 | AUVON, Gel seat cushion, model SO7682, AUVON, Cooling Gel Wheelchair Seat Cushion, model SW6652, AUVON, Gel seat cushion, model SW1651, AUVON, Anti-Slip Wheelchair Cushions, model SW4111 | 2025 | 101 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class 2 | AUVON,BLOOD GLUCOSE TEST STRIPS & STERILE LANCETS, model DS-W, AUVON, Lancing Device & Twist Lancets, Auvon, Sterile Lancets, AUVON, BLOOD GLUCOSE MONITORING SYSTEM, model DS-W | 2022 | 21 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | AUVON, Wireless TENS & EMS Unit, model TX6224, AUVON, TENS and EMS Unit, model TC3241, AUVON, Tens & Ems Device, model TU1080, AUVON, OTC TENS & EMS Unit, model TA2224, AUVON, OTC TENS & EMS Unit, model TA3224, AUVON, OTC TENS & EMS Unit, model TU2424 and 7 more | 2025 | 66 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | AUVON, Wireless TENS & EMS Unit, model TX6224, AUVON, TENS and EMS Unit, model TC3241, AUVON, Tens & Ems Device, model TU1080, AUVON, OTC TENS & EMS Unit, model TA2224, AUVON, OTC TENS & EMS Unit, model TA3224, AUVON, OTC TENS & EMS Unit, model TU2424 and 7 more | 2025 | 57 |
| System, Test, Blood Glucose, Over The Counter | Class 2 | AUVON, BLOOD GLUCOSE TEST STRIPS & STERILE LANCETS, model DS-W, AUVON, BLOOD GLUCOSE TEST STRIPS, model DS-W, AUVON, BLOOD GLUCOSE MONITORING SYSTEM, model DS-W | 2018 | 20 |
Own-Brand Listings
Clearances
No clearance names Shenzhen Yuwen E-Commerce Co., Ltd. as applicant. 10 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251429 | 2025-08-28 | NUH | Special | Changsha Anxiang Medical Technology Co., Ltd. |
| K251706 | 2025-07-30 | NGX | Special | Changsha Anxiang Medical Technology Co., Ltd. |
| K250360 | 2025-05-11 | NUH | Traditional | Shenzhen Jiantuo Electronics Co., Ltd. |
| K250053 | 2025-05-09 | NUH | Traditional | Shenzhen Jiantuo Electronics Co., Ltd. |
| K243763 | 2025-03-12 | NGX | Traditional | Changsha Anxiang Medical Technology Co., Ltd. |
| K243511 | 2025-02-10 | NGX | Traditional | Changsha Anxiang Medical Technology Co., Ltd. |
| K242787 | 2024-12-18 | NGX | Traditional | Changsha Anxiang Medical Technology Co., Ltd. |
| K242567 | 2024-11-04 | NUH | Traditional | Changsha Anxiang Medical Technology Co., Ltd. |
| K222770 | 2022-12-13 | GYB | Traditional | Top-rank Health Care Co., Ltd. |
| K160138 | 2016-08-11 | GXY | Traditional | Gmdasz Manufacturing Co., Ltd. |
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.