FDA Registration
Active
🇨🇳 China
BIOXIN MEDICAL CO., LTD
Reg #: 3008496528
·
FEI: 3008496528
·
Expires 2026
Products
8
Proprietary Names
17
Establishment Types
1
Classifications
8
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Registration Details
- Registration Name
- BIOXIN MEDICAL CO., LTD
- Registration Number
- 3008496528
- FEI Number
- 3008496528
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 288-13 Shanhai 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 |
|---|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2026-06-02 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2026-06-02 |
| Probe, Thermodilution | KRB | Class 2 | Cardiovascular | No | 2007-11-29 |
| 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, Embolectomy | DXE | Class 2 | Cardiovascular | No | 2007-11-29 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2007-11-29 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2025-06-16 |
Proprietary Names
Bioptimal Pulmonary Artery Monitoring Catheter
Safetywedge¿ Relief
and Accessories
Thermodilution Catheter
Biotrans¿ Pressure Monitoring Kits
Biotrans¿ Reusable Sensor Base
Thermodilution Catheter and
Catheter and Accessories
Heparin Coated Thermodilution
Inline Sensor Assembly and
Silicon Foley Catheter
Bioport System
Accutrans¿ Disposable
Pressure Monitoring System
Bioptimal Embolectomy Catheter
Bioptimal Central Venous Catheter
Bioptimal Bipolar Pacing Catheter
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)