FDA Registration
Active
🇺🇸 United States
MouthLab
Reg #: 3023412068
·
FEI: 3023412068
·
Expires 2025
Products
7
Proprietary Names
2
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- AIDAR HEALTH, INC
- Registration Number
- 3023412068
- FEI Number
- 3023412068
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8920 State Route 108, Suite B
- City
- Columbia
- State
- MD
- ZIP
- 21045
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201635
Owner / Operator
- Firm Name
- Aidar Health, Inc
- Operator Number
- 10086144
- Address
- 3402 Birch Hollow Rd
- City
- Pikesville
- State
- MD
- Postal Code
- 21208
- Country
- US
- Correspondent
- Sathya Elumalai
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-10-18 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2022-10-18 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-10-18 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2022-10-18 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-10-18 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-10-18 |
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2022-10-18 |
Proprietary Names
MouthLab
Aidar Health
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device