FDA Registration
Active
🇺🇸 United States
SUNTECH MEDICAL, INC.
Reg #: 1036863
·
FEI: 1036863
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- SUNTECH MEDICAL, INC.
- Registration Number
- 1036863
- FEI Number
- 1036863
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5827 S. Miami Boulevard, Suite 100
- City
- MORRISVILLE
- State
- NC
- ZIP
- 27560
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151520
Owner / Operator
- Firm Name
- SUNTECH MEDICAL, INC.
- Operator Number
- 1036863
- Address
- 5827 S. Miami Boulevard, Suite 100
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2016-02-21 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2006-12-07 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2016-07-13 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2016-07-13 |
Proprietary Names
SunTech Oscar 2, 24-HR ABPM
Oscar 2, Model 250
ALL PURPOSE CUFF
Disposable Cuff
Tango M2
CT40 Vital Signs
Establishment Types
Manufacture Medical Device