Data / Medical devices / China / Wenzhou Longwan Medical Device Factory
Wenzhou Longwan Medical Device Factory: FDA-registered device maker in Wenzhou Zhejiang, China, 2 510(k) clearances
Wenzhou Longwan Medical Device Factory is registered with the FDA (registration 3006113277) in Wenzhou Zhejiang, China. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 20, 2024. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006113277
- Address
- Unit 4, Building 27, No. 706 Yanyun Road, Oujiangkou Industrial Cluster District, Wenzhou Zhejiang, China, 325026
- Owner or operator
- Wenzhou Longwan Medical Device Factory (10062272)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- January 7, 2020
- Registered through
- 2026
- Brand names listed
- Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer, BLOOD PRESSURE CUFF, BOTTLE, HOT/COLD WATER, Goniometer, nonpowered, INFUSOR, PRESSURE, FOR I.V. BAGS, Kit, first aid, talking, OTOSCOPE, Percussion Hammer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bottle, Hot/Cold Water | FPF | 1 | Manufacturer | accessdata.fda.gov |
| Goniometer, Nonpowered | KQW | 1 | Manufacturer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Manufacturer | accessdata.fda.gov |
| Kit, First Aid, Talking | OVR | 1 | Manufacturer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Manufacturer | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Manufacturer | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 20, 2024 | K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | DXQ | Substantially Equivalent | Wenzhou Longwan Medical Device Factory | accessdata.fda.gov |
| June 9, 2006 | K060871 | AS101, BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | Wenzhou Longwan Medical Instrument Company | accessdata.fda.gov |
Compare with other makers
- All makers of Blood Pressure Cuff
- All makers of Infusor, Pressure, For I.V. Bags
- All makers of Tourniquet, Nonpneumatic
- All makers of Hammer, Surgical
- All makers of Light, Examination, Medical, Battery Powered
- All makers of Stethoscope, Manual
Updated March 20, 2024. 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.