FDA Registration
Active
🇨🇳 China
Sol-Care Safety Pen Needle
Reg #: 3015955792
·
FEI: 3015955792
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SANDSTONE MEDICAL (SUZHOU) INC.
- Registration Number
- 3015955792
- FEI Number
- 3015955792
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 6, No.168 PuTuoShan Road, New District
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K210864
Owner / Operator
- Firm Name
- Sandstone Medical (Suzhou) INC.
- Operator Number
- 10080666
- Address
- Building 6, No.168 PuTuoShan Road, New District
- City
- Suzhou
- State
- Jiangsu
- Postal Code
- 215153
- Country
- CN
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2022-03-02 |
Proprietary Names
Sol-Care Safety Pen Needle
ONE-CARE DUO Safety Pen Needle
Safety Pen Needle
Microdot Safety Pen Needle
Establishment Types
Manufacture Medical Device