Touchstone International Medical Science Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 5 device types, 2 clearances.
Touchstone International Medical Science Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Clamp, Penile, Stapler, Surgical and 3 other device types. Its earliest product listing with the FDA dates from 2008.
5device types registered with the FDA
2510(k) clearances
Registration
| Registered name | TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007222388 |
| FEI number | 3007222388 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 天臣国际医疗科技股份有限公司 |
|---|---|
| Source | EMIS company database |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 278 Dongping Street, Suzhou Industrial Park, |
| Postal code | 215123 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Suturing, Stomach And Intestinal | Class 1 | Auto Purse String Clamp for Single Use | 2008 | 4 |
| Clamp, Penile | Class 1 | Touchstone Incontinence Clamp | 2023 | 3 |
| Staple, Implantable | Class 2 | ELC, FELC and SELC Series Endoscopic Linear Cutter and Single Use Loading Unit, LS Series Linear Stapler and Reloads, LC Series Linear Cutter and Reloads, CLC Series Curved Linear Cutter and Reloads, PPH Series PPH Stapler and Purse Sets for Single Use, TST Series Tissue-Selecting Therapy Stapler and 2 more | 2016 | 16 |
| Staple, Removable (Skin) | Class 1 | Circumcision Stapler for Single Use | 2019 | 20 |
| Stapler, Surgical | Class 2 | ELC, FELC and SELC Series Endoscopic Linear Cutter and Single Use Loading Unit, LS Series Linear Stapler and Reloads, LC Series Linear Cutter and Reloads, CLC Series Curved Linear Cutter and Reloads | 2016 | 16 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K141097 | 2014-09-26 | GDW | Traditional | This company |
| K141367 | 2014-07-25 | GDW | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Main products | Powered universal handles, Circular staplers, Endoscopic linear cutters, Linear staplers, Linear cutters |
| Export markets | 60+ countries |
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.
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