Zhejiang Kairui Medical Device Co., Ltd.
Registered establishment in Ruian, Zhejiang, China. 4 device types, 2 clearances.
Zhejiang Kairui Medical Device Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Crutch, Walker, Mechanical and 2 other device types. Its earliest product listing with the FDA dates from 2024.
4device types registered with the FDA
2510(k) clearances
Registration
| Registered name | ZHEJIANG KAIRUI MEDICAL DEVICE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3032014158 |
| FEI number | 3032014158 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 浙江凯瑞医疗器械有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Ruian |
|---|---|
| Province | Zhejiang |
| Address | No.85, Dengyun Road, Tangxia Town |
| Postal code | 325204 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Chair, With Casters | Class 1 | Transport Wheelchair | 2026 | 85 |
| Crutch | Class 1 | Walking Stick | 2024 | 112 |
| Walker, Mechanical | Class 1 | Rollator | 2024 | 183 |
| Wheelchair, Powered | Class 2 | Electric wheelchair (KR-8807), Electric Wheelchair (KR8803) | 2024 | 62 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K241588 | 2024-11-25 | ITI | Traditional | This company |
| K242791 | 2024-11-12 | ITI | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Ruian Sunnyworld International Trade Co., Ltd. | 10 |
| Wenzhou Lingfeng Electronic Technology Co., Ltd. | 4 |
| Zhejiang Laymas Health Technology Co., Ltd. | 1 |
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.