Changzhou Ankang Medical Instruments Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 1 device type, 1 clearance.
Changzhou Ankang Medical Instruments Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Stapler, Skin. Its earliest product listing with the FDA dates from 2024.
1device type
1510(k) clearance
Registration
| Registered name | CHANGZHOU ANKANG MEDICAL INSTRUMENTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009273652 |
| FEI number | 3009273652 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 常州安康医疗器械有限公司 |
|---|---|
| Unified social credit code | 91320412551197911C |
| Source | NMPA UDI database |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No.17 Jinfeng Road |
| Postal code | 213146 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Stapler, Skin | Class 1 | Disposable Skin Stapler AKYPF 55 A/B, Disposable Skin Stapler AKYPF 35 A/B | 2024 | 22 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K231042 | 2023-06-08 | GCJ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | CAK Surgical Anastomosis Devices, Minimally Invasive Surgical Instruments |
| Certifications | ISO 13485, ISO 9001, CFDA, CE, FDA |
| Export markets | Europe, North America, Southeast Asia, 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.