Bioxin Medical Co., Ltd.
Registered establishment in Weihai, Shandong, China. 8 device types.
Bioxin Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Catheter, Embolectomy, Probe, Thermodilution and 6 other device types. Its earliest product listing with the FDA dates from 2007.
Registration
| Registered name | BIOXIN MEDICAL CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3040153768 |
| FEI number | 3040153768 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Location
| City | Weihai |
|---|---|
| Province | Shandong |
| Address | No. 300-4 Huoju Road |
| Postal code | 264209 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Embolectomy | Class 2 | Bioptimal Embolectomy Catheter | 2007 | 1 |
| Catheter, Flow Directed | Class 2 | Bioptimal Pulmonary Artery Monitoring Catheter | 2026 | 1 |
| Catheter, Intravascular, Diagnostic | Class 2 | Bioptimal Pulmonary Artery Monitoring Catheter, Thermodilution Catheter and, Catheter and Accessories, Heparin Coated Thermodilution, Inline Sensor Assembly and, and Accessories and 1 more | 2007 | 11 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | Bioptimal Central Venous Catheter | 2007 | 12 |
| Catheter, Retention Type, Balloon | Class 2 | Silicon Foley Catheter | 2020 | 17 |
| Electrode, Pacemaker, Temporary | Class 2 | Bioptimal Bipolar Pacing Catheter | 2025 | 3 |
| Probe, Thermodilution | Class 2 | Safetywedge Relief | 2007 | 3 |
| Transducer, Blood-Pressure, Extravascular | Class 2 | Biotrans Pressure Monitoring Kits, Biotrans Reusable Sensor Base, Accutrans Disposable, Pressure Monitoring System, Bioport System | 2007 | 7 |
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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