CARE LIVING DIAGNOSTICS INC

FDA Device Registration & Listing · South Setauket, NY, US · Registration 3031259044

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031259044
FEI Number
3031259044
Entity Name
CARE LIVING DIAGNOSTICS INC
City/State/Country
South Setauket, NY, US
Establishment Address
43 Sunflower Ridge Rd, South Setauket, NY 11720, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Care Living Diagnostics Inc (Owner Number: 10090880)
Owner / Operator Contact Address
43 Sunflower Ridge Rd, South Setauket, NY 11720, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Astrasono Bladder Scanner A3Pro/A3Pro Lite/A3Essential/A5Pro

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-12-23
MEG Syringe, Antistick General Hospital Class 2 880.5860 2025-09-17
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-09-17
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2025-09-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-05-25
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-05-25
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2024-05-27
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2024-05-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2024-05-27
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2025-11-20

Official Correspondent

Wendy Yang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Care Living Diagnostics Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031259044. Last updated year: 2026. Please use registration number 3031259044 when referencing this establishment in official correspondence.
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