FDA Registration
Active
🇨🇳 China
Infinity Endo Diamond Burs
Reg #: 3015136927
·
FEI: 3015136927
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- SHENZHEN ROGIN MEDICAL CO., LTD
- Registration Number
- 3015136927
- FEI Number
- 3015136927
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist
- City
- shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- SHENZHEN ROGIN MEDICAL CO., LTD
- Operator Number
- 10058732
- Address
- Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518129
- Country
- CN
- Correspondent
- Xiaoran Xu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bur, Dental | EJL | Class 1 | Dental | No | 2018-10-24 |
Proprietary Names
Infinity Endo Diamond Burs
Silicon Polisher/Diamond Polisher/Tungsten Cutter/Finishing Stones
Dental Burs(Diamond Burs/Carbide Burs), Rubber Diamond Polisher, Rubber Diamond Polisher
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)