Data / Medical devices / China / Wenzhou Dongfang Medical Instruments Co., Ltd
Wenzhou Dongfang Medical Instruments Co., Ltd: FDA-registered device maker in WENZHOU Zhejiang, China, 1 510(k) clearance
Wenzhou Dongfang Medical Instruments Co., Ltd is registered with the FDA (registration 3004784770) in WENZHOU Zhejiang, China. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 15, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004784770
- Address
- #143, Zhongxin Road, Wenzhou Industry Zone, WENZHOU Zhejiang, China, 325013
- Owner or operator
- WENZHOU KINDCARE IMPORT & EXPORT CO.,LTD (9066722)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- September 16, 2004
- Registered through
- 2026
- Brand names listed
- B.P. MONITOR WITH STETHOSCOPE, Bandage Scissors, Blood Pressure Cuff, Blood Pressure Monitor, Disposable Face Mask, Face Shield, Goggles, INJECTION PAD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 15, 2008 | K081951 | ANEROID SPHYGMOMANOMETER, MODEL KT-A01 | DXQ | Substantially Equivalent | Wenzhou Kindcare Import & Export Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Blood Pressure Cuff
- All makers of Accessory, Surgical Apparel
- All makers of Scissors, General, Surgical
- All makers of Non-Surgical Gown
- All makers of Otoscope
- All makers of Tourniquet, Nonpneumatic
Updated August 15, 2008. 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.