FDA Registration
Inactive
🇨🇳 China
BIOXIN MEDICAL CO., LTD
·
Expires 2026
Products
8
Proprietary Names
17
Establishment Types
1
Classifications
8
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Registration Details
- Registration Name
- BIOXIN MEDICAL CO., LTD
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 300-4 Huoju Road, Torch Hi-tech Science Park
- City
- Weihai Shandong
- Country
- CN
Owner / Operator
- Firm Name
- BIOPTIMAL INTERNATIONAL PTE LTD
- Operator Number
- 9004883
- Address
- 14 Kaki Bukit View
- City
- Singapore
- State
- South East
- Postal Code
- 415950
- Country
- SG
- Correspondent
- John Yong Ji - Min
US Agent
- Business Name
- BIOMEDICAL SALES INTERNATIONAL, INC.
- Contact Name
- Dennis Bassett
- Address
- 457 W Virginia Ave
- City
- Punta Gorda
- State
- FL
- ZIP
- 33950
- Country
- US
- [email protected]
- Phone
- 513 2586555
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2007-11-29 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2020-09-13 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2007-11-29 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2010-01-07 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2025-06-16 |
| Catheter, Embolectomy | DXE | Class 2 | Cardiovascular | No | 2007-11-29 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2007-11-29 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2026-06-02 |
Proprietary Names
Biotrans¿ Pressure Monitoring Kits
Silicon Foley Catheter
Bioptimal Central Venous Catheter
and Accessories
Thermodilution Catheter
Bioptimal Bipolar Pacing Catheter
Catheter and Accessories
Heparin Coated Thermodilution
Bioptimal Embolectomy Catheter
Inline Sensor Assembly and
Safetywedge¿ Relief
Thermodilution Catheter and
Bioptimal Pulmonary Artery Monitoring Catheter
Accutrans¿ Disposable
Pressure Monitoring System
Bioport System
Biotrans¿ Reusable Sensor Base
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)