FDA Registration
Active
🇨🇳 China
BQ PLUS MEDICAL CO.,LTD
Reg #: 3013023255
·
FEI: 3013023255
·
Expires 2026
Products
13
Proprietary Names
8
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- BQ PLUS MEDICAL CO.,LTD
- Registration Number
- 3013023255
- FEI Number
- 3013023255
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.18, CHEYE RD, CHEDUN TOWN
- City
- SONGJIANG Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K242126
Owner / Operator
- Firm Name
- BQ PLUS MEDICAL CO.,LTD
- Operator Number
- 10054083
- Address
- NO.18, CHEYE RD, CHEDUN TOWN
- City
- SONGJIANG
- State
- Shanghai
- Postal Code
- 201611
- Country
- CN
- Correspondent
- LU HAN
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Chicago
- State
- IL
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-11-17 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2019-09-19 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2019-02-21 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2017-12-13 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2025-11-26 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2025-11-26 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2025-11-26 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2025-11-26 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2025-11-26 |
| Endoscopic Cytology Brush | FDX | Class 2 | Gastroenterology, Urology | No | 2025-11-26 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2025-11-26 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2025-11-24 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2025-11-26 |
Proprietary Names
anesthesia face mask
Endoscopic Distal Attachment (AF-D series)
Disposable Injection Needle AF series
Ureteral Stents (AF-D series)
Disposable Cytology Brush (AF series)
Disposable Endoscope Valves Set (AF series)
KMC Kyphoplasty System
Disposable Hemoclip (AF series)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)