Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2082313

FEI Number

2082313

Entity Name

A&D ENGINEERING, INC.

City/State/Country

Ann Arbor, MI, US

Establishment Address

4622 Runway Boulevard, Ann Arbor, MI 48108, 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

K002182

PMA Number

N/A

All Registered Proprietary Names

TM-CF602D TM-2440 & TM-2441 TM-CF702D A&D Medical UB-543 A&D Medical UM-211 Digital Blood Pressure Monitor 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 DT-105 Thermometer UA-767PVS UA-767Plus UA-787EJ UA-611 UA-787 UA-767PSAC UltraConnect UB-1100BLE Blood Pressure Monitor UA-1030T UA-1020 DT-102 DT-103 UB-525 Digital Blood Pressure Monitor UA-704 System, Measurement, Blood Pressure Non-invasive UA-705 UA-705V UA-705VL UltraConnect UA-1200BLE Blood Pressure Monitor UA-1200CNBLE

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	2019-06-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-01-26
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	2005-09-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-06-24
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
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	2011-12-07
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	2005-09-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-06-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-08-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2014-01-03

Official Correspondent

No official correspondent registered.

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
3004128050	A&D Electronics (Shenzhen) Co., Ltd.	Shenzhen Guangdong, CN

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.

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2082313. Last updated year: 2026. Please use registration number 2082313 when referencing this establishment in official correspondence.