Data / Medical devices / China / Wenzhou Yosun Medical Technology Co., Ltd.
Wenzhou Yosun Medical Technology Co., Ltd.: FDA-registered device maker in Wenzhou Zhejiang, China, 2 510(k) clearances
Wenzhou Yosun Medical Technology Co., Ltd. is registered with the FDA (registration 3017858797) in Wenzhou Zhejiang, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017858797
- Address
- No.17, Shahong Road, Lingmen, Beibaixiang Town, Yueqing, Wenzhou Zhejiang, China, 325603
- Owner or operator
- Wenzhou Yosun Medical Technology Co., Ltd. (10078638)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 30, 2020
- Registered through
- 2026
- Brand names listed
- Digital Thermometer, Digital thermometer (YD-101, YD-102, YD-105, YD-106, YD-202, YD-203, YD-205, YD-206), Infrared thermometer(YI-100,YI-200,YI-300,YI-400), System, measurement, blood-pressure, non-invasive, Thermometer, electronic, clinical
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| December 15, 2023 | K231478 | Digital Blood Pressure Monitor (Model: YB-800) | DXN | Substantially Equivalent | Wenzhou Yosun Medical Technology Co.,Ltd | accessdata.fda.gov |
| October 23, 2020 | K201843 | Infrared ear and forehead thermometer, model YI-100 | FLL | Substantially Equivalent | Wenzhou Yosun Medical 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 Clinical Electronic Thermometer
Updated December 15, 2023. 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.