Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013920399

FEI Number

3013920399

Entity Name

A&D Vietnam Limited

City/State/Country

Tu Son Ward Bac Ninh, VN

Establishment Address

No. 28, Street 5, VSIP Bac Ninh Integrated Township and Industrial Park, Tu Son Ward Bac Ninh ----, VN

Establishment Type(s)

Manufacture 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

K141201

PMA Number

N/A

All Registered Proprietary Names

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 UltraConnect UB-1100BLE Blood Pressure Monitor UA-767PVS UA-767Plus UA-787EJ UA-611 UA-787 UA-767PSAC UA-789AC UA-420 UA-767FAC UA-767F UA-4010WM UA-651 UA-651SAC UA-651LAC UA-651BLE UM-WRRS2M1KEC

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	2005-09-09
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	2014-05-29
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-01-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-10-21

Official Correspondent

No official correspondent registered.

US Agent Details

Adam Huddle Business: A&D Engineering, Inc. Email: ahuddle@andonline.com Phone: (734) 2095821

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
2082313	A&D ENGINEERING, INC.	Ann Arbor, MI, US
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.

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3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013920399. Last updated year: 2026. Please use registration number 3013920399 when referencing this establishment in official correspondence.