FDA Registration
Active
🇨🇳 China
PureRegen Gel Sinus
Reg #: 3007327621
·
FEI: 3007327621
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BIOREGEN BIOMEDICAL (CHANGZHOU) CO., LTD
- Registration Number
- 3007327621
- FEI Number
- 3007327621
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building B, No. 117, Xueye Road
- City
- Changzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- BioRegen Biomedical (Changzhou) Co., Ltd
- Operator Number
- 10027304
- Address
- Building B, No. 117, Xueye Road
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213125
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2008-10-23 |
Proprietary Names
PureRegen Gel Sinus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device