Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044174020

FEI Number

3044174020

Entity Name

A and D Engineering, Inc.

City/State/Country

Hoschton, GA, US

Establishment Address

1075 Highway 124W, Building 400, Suite 150, Hoschton, GA 30548, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

A&D Company, Limited (Owner Number: 8031633)

Owner / Operator Contact Address

3-23-14 HIGASHI-IKEBUKURO, TOSHIMA-KU, JP-13 170-0013, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

UltraConnect UA-1200BLE Blood Pressure Monitor UA-1200CNBLE A&D Medical UM-211 Digital Blood Pressure Monitor UA-660 UA-651M-AC UA-651W-AC UA-651 UA-651S-AC UA-651L-AC UA-611 UA-660CN UM-SARS4K1KEC UM-AURS2M1KEC UM-SARS2M1KEC UM-212BLE Blood Pressure Monitor UM-AURS4K1KEC UM-SSRS2M1KEC UM-LLRS4K1KEC UM-LARS4K1KEC UM-LARS2M1KEC UM-SSRS4K1KEC UM-LLRS2M1KEC A&D Medical UB-543 DT-105 Thermometer UA-767PVS UA-767Plus UA-787EJ UA-611 UA-787 UA-767PSAC UC-352BLE-V UC-352CEL UA-651BLE UA-651BLE-V UA-651BLES-V UA-651CEL-SM UA-1020CEL UA-810BLE UA-372A UA-1040TBLE UA-910BLE UA-770BLE UA-6010BLEWM UA-8010BLEWM UA-1020CEL-CS UA-1030T UA-1020 UB-525 Digital Blood Pressure Monitor DT-102 DT-103 UC-450BLE-CV UC-450BLE

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	2017-08-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-06-24
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-03-27
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-10-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-12-27
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-12-27
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2014-01-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-01-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-10-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-05-29
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2005-09-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2005-09-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-12-07
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2005-09-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2014-01-03
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2023-10-12

Official Correspondent

Adam Huddle

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

A&D Company, Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012935929	A&D SCALES CO., LTD.	Jincheon-gun Chungbuk, KR
3006899423	A&D Manufacturing Company, Limited - Tsukuba Factory	Shimotsuma-shi Ibaraki, JP
1054421	A&D Engineering, Inc.	Duluth, GA, US
3013920399	A&D Vietnam Limited	Tu Son Ward Bac Ninh, VN
2082313	A&D ENGINEERING, INC.	Ann Arbor, MI, US

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044174020. Last updated year: 2026. Please use registration number 3044174020 when referencing this establishment in official correspondence.