Wenzhou Longwan Medical Device Factory
Registered establishment in Wenzhou, Zhejiang, China. 11 device types, 1 clearance.
Wenzhou Longwan Medical Device Factory is a contract manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Hammer, Surgical and 9 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | WENZHOU LONGWAN MEDICAL DEVICE FACTORY |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006113277 |
| FEI number | 3006113277 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 温州隆湾医疗器械有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Wenzhou |
|---|---|
| Province | Zhejiang |
| Address | Unit 4, Building 27, No. 706 Yanyun Road, Oujiangkou Industrial Cluster District |
| Postal code | 325026 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | Blood Pressure Cuff, Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | 2022 | 50 |
| Bottle, Hot/Cold Water | Class 1 | Bottle, HOT/Cold Water | 2023 | 37 |
| Goniometer, Nonpowered | Class 1 | Goniometer, nonpowered | 2023 | 14 |
| Hammer, Surgical | Class 1 | Percussion Hammer | 2020 | 20 |
| Infusor, Pressure, For I.V. Bags | Class 1 | Infusor, Pressure, FOR I.V. Bags | 2023 | 25 |
| Kit, First Aid, Talking | Class 1 | Kit, first aid, talking | 2023 | 18 |
| Light, Examination, Medical, Battery Powered | Class 1 | penlight | 2020 | 53 |
| Otoscope | Class 1 | Otoscope | 2023 | 43 |
| Scissors, Medical, Disposable | Class 1 | Scissors, Medical, Disposable | 2023 | 36 |
| Stethoscope, Manual | Class 1 | Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer, Stethoscope | 2020 | 64 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet | 2020 | 124 |
Clearances
1 clearance names Wenzhou Longwan Medical Device Factory as applicant. 1 is held by another company 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 |
|---|---|---|---|---|
| K240165 | 2024-03-20 | DXQ | Traditional | This company |
| K060871 | 2006-06-09 | DXQ | Traditional | Wenzhou Longwan Medical Instrument Company |
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.