FDA Registration
Active
🇨🇳 China
Sterile High-Pressure Angiographic Syringes For Single-Use, Models: 100123, 100125, 100110, 100120, 100112, 100122
Reg #: 3012395857
·
FEI: 3012395857
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shenzhen Boon Medical Supply Co., Ltd.
- Registration Number
- 3012395857
- FEI Number
- 3012395857
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K241109
Owner / Operator
- Firm Name
- Shenzhen Boon Medical Supply Co., Ltd
- Operator Number
- 10051055
- Address
- No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518173
- Country
- CN
US Agent
- Business Name
- Darco International Corporation
- Contact Name
- Ann Hamilton Ruben
- Address
- 510 Shotgun Road Ste. 520
- City
- Sunrise
- State
- FL
- ZIP
- 33326
- Country
- US
- [email protected]
- Phone
- 954 3808595
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2025-05-20 |
Proprietary Names
Sterile High-Pressure Angiographic Syringes For Single-Use, Models: 100123, 100125, 100110, 100120, 100112, 100122
Connection tube, Models: 400204
Sterile High-Pressure Angiographic Syringes For Single-Use, Models: 300107, 200105, 200113, 200110, 200111
Transfer set, Models: 700204-1, 700204-2, 700205-1, 700205-2, 700206, 700207-1, 700207-2
Establishment Types
Manufacture Medical Device