FDA Registration
Active
🇺🇸 United States
SIMPLE DIAGNOSTICS
Reg #: 3007384659
·
FEI: 3007384659
·
Expires 2026
Products
9
Proprietary Names
0
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- SIMPLE DIAGNOSTICS
- Registration Number
- 3007384659
- FEI Number
- 3007384659
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5208 Grand Ave, Suite 201
- City
- Maspeth
- State
- NY
- ZIP
- 11378
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133059
Owner / Operator
- Firm Name
- Simple Diagnostics
- Operator Number
- 10028449
- Address
- 52-08 Grand Ave, Suite 201
- City
- Maspeth
- State
- NY
- Postal Code
- 11378
- Country
- US
- Correspondent
- Muhammad arif
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2016-10-26 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2020-01-10 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2020-01-10 |
| Holding Chambers, Direct Patient Interface | NVP | Class 2 | Anesthesiology | No | 2016-10-27 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2019-11-11 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2019-11-06 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2016-10-26 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2010-03-10 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2021-03-04 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198