Wenzhou Kangju Medical Instrument Co., Ltd.
Registered establishment in Wenzhou, Zhejiang, China. 15 device types.
Wenzhou Kangju Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cane, Pinwheel and 13 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3016170451 |
| FEI number | 3016170451 |
| Establishment type | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 温州市康聚医疗仪表有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Wenzhou |
|---|---|
| Province | Zhejiang |
| Address | 81 Liuzhai Luodong South Street |
| Postal code | 325000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Hygiene | Class 1 | Adaptor, Hygiene | 2025 | 193 |
| Blood Pressure Cuff | Class 2 | Aneroid Sphygmomanometer, Blood Pressure Monitor, Wenzhou Kangju Blood Pressure Cuff | 2012 | 50 |
| Bottle, Hot/Cold Water | Class 1 | Model OT-HWB,OT-RC, Bottle hot/cold water | 2011 | 37 |
| Cane | Class 1 | Cane | 2025 | 97 |
| Cushion, Flotation | Class 1 | Cushion Pad | 2015 | 52 |
| Fork, Tuning | Class 1 | Fork | 2011 | 11 |
| Light, Examination, Medical, Battery Powered | Class 1 | Penlight | 2018 | 53 |
| Massager, Therapeutic, Electric | Class 1 | Foot Spa Massager, Foot Massager, Neck and Shoulder Massager, Massage Cushion, Massage Hammer, Massage Pillow; Massage G | 2023 | 437 |
| Pad, Heating, Powered | Class 2 | Heating Pad | 2023 | 144 |
| Percussor | Class 1 | Percussor | 2011 | 13 |
| Pinwheel | Class 1 | Pinwheel | 2011 | 3 |
| Scissors, General, Surgical | Class 1 | Scissors | 2024 | 83 |
| Stethoscope, Manual | Class 1 | Stethoscope manual | 2011 | 64 |
| Tape, Measuring, Rulers And Calipers | Class 1 | Tape, Measuring, Rulers AND Calipers | 2020 | 42 |
| Walker, Mechanical | Class 1 | Walker, Mechanical | 2020 | 183 |
Clearances
No clearance names Wenzhou Kangju Medical Instrument Co., Ltd. as applicant. 2 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 |
|---|---|---|---|---|
| K222652 | 2022-11-28 | DXQ | Traditional | Cardicare Company, Ltd. |
| K122259 | 2012-09-24 | DXQ | Traditional | Hangzhou Reli-On Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Main products | Aneroid sphygmomanometers, Mercury sphygmomanometers, Stethoscopes |
| Export markets | North America, South America, Europe, Southeast Asia, Middle East, Africa |
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.