FDA Registration
Active
🇺🇸 United States
Sanbor Medical
Reg #: 3007113169
·
FEI: 3007113169
·
Expires 2026
Products
6
Proprietary Names
2
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- Sanbor Medical
- Registration Number
- 3007113169
- FEI Number
- 3007113169
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7584 Morris Court, Suite 218
- City
- Allentown
- State
- PA
- ZIP
- 18106
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233089
Owner / Operator
- Firm Name
- Sanbor Medical
- Operator Number
- 10028522
- Address
- 7584 Morris Court, Suite 218
- City
- Allentown
- State
- PA
- Postal Code
- 18106
- Country
- US
- Correspondent
- Wayne Meng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2016-02-22 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-01-27 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-01-27 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2025-01-27 |
| Prosthesis, Toe, Constrained, Polymer | KWH | Class 2 | Orthopedic | No | 2025-01-27 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2023-09-13 |
Proprietary Names
Spiro PD Personal Spirometer
ReBuilder-2407; ReBuilder-300
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198