Canwell Medical Co., Ltd.
Registered establishment in Jinhua, Zhejiang, China. 42 device types, 3 clearances.
Canwell Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Clamp, Reamer and 40 other device types. Its earliest product listing with the FDA dates from 2008.
42device types registered with the FDA
3510(k) clearances
Registration
| Registered name | CANWELL MEDICAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006395932 |
| FEI number | 3006395932 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 浙江科惠医疗器械股份有限公司 |
|---|---|
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Jinhua |
|---|---|
| Province | Zhejiang |
| Address | No. 466, South Xianhua Street., |
| Postal code | 321016 |
| Country | China |
What It Makes
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242973 | 2025-04-24 | HRS | Abbreviated | This company |
| K161151 | 2016-09-21 | MNH | Traditional | This company |
| K142943 | 2015-08-03 | HRS | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1994 |
|---|---|
| Main products | Trauma systems, Spinal systems, Joint systems, Dental systems, Orthopedic power tools |
| Certifications | National High-Tech Enterprise, Specialized and Sophisticated Small Giant Enterprise, National Intellectual Property Demonstration Enterprise, Zhejiang Province Hidden Champion |
| Export markets | Global (partner to top five orthopedic device companies) |
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.