FDA Registration
Active
🇺🇸 United States
CARE LIVING DIAGNOSTICS INC
Reg #: 3031259044
·
FEI: 3031259044
·
Expires 2026
Products
12
Proprietary Names
1
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- CARE LIVING DIAGNOSTICS INC
- Registration Number
- 3031259044
- FEI Number
- 3031259044
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 43 Sunflower Ridge Rd
- City
- South Setauket
- State
- NY
- ZIP
- 11720
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242721
Owner / Operator
- Firm Name
- Care Living Diagnostics Inc
- Operator Number
- 10090880
- Address
- 43 Sunflower Ridge Rd
- City
- South Setauket
- State
- NY
- Postal Code
- 11720
- Country
- US
- Correspondent
- Wendy Yang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-12-23 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2025-09-17 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-09-17 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2025-09-24 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2026-05-25 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2026-05-25 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2024-05-27 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2024-05-27 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2024-05-27 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2025-11-20 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2025-12-23 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2025-11-20 |
Proprietary Names
Astrasono Bladder Scanner A3Pro/A3Pro Lite/A3Essential/A5Pro
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility