FDA Registration
Active
🇺🇸 United States
CORDX LABS, INC.
Reg #: 3034405508
·
FEI: 3034405508
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- CORDX LABS, INC.
- Registration Number
- 3034405508
- FEI Number
- 3034405508
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5900 Windward Pkwy Ste 335
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210564
Owner / Operator
- Firm Name
- CorDx Labs, Inc.
- Operator Number
- 10092206
- Address
- 5900 Windward Parkway, Suite 335
- City
- Alpharetta
- State
- GA
- Postal Code
- 30005
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-12-17 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2026-01-28 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-12-17 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2025-04-10 |
Proprietary Names
CorDx @AL21 Infrared Thermometer
CorDx @AL21 Arm Blood Pressure Monitor
CorDx @AL21 Fingertip Pulse Oximeter
CorDx @AL21 First Aid Kit
First Aid Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility