Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020848330

FEI Number

3020848330

Entity Name

TELSTAR VIETNAM COMPANY LIMITED

City/State/Country

Bac Ninh, VN

Establishment Address

Part of LOT CN-06, and CN-07, Van Trung Industrial Park, Nenh Ward, Bac Ninh Province, Bac Ninh 236101, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shenzhen AOJ Medical Technology Co., Ltd. (Owner Number: 10059056)

Owner / Operator Contact Address

Room 301&4-5F, Block A, Building A, Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, Xixiang Street, Bao'an District, Shenzhen, CN-GD 518126, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WRS-35P, WRS-35S, WRS-35E, XS Mini Wrist Blood Pressure Monitor, AOJ-35A,AOJ-35B,WRS-35B,AOJ-35D,AOJ-35E,AOJ-35F, AOJ-35G,WRS-35G,WRS-35H,WRS-35K,WRS-35N 3-in-1 Ear, Forehead +Touchless Thermometer, AOJ-20R Infrared Thermometer, AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ- 20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20Y JB9607, TM 550 BU 518,ARM-30U,ARM-3030,ARM-30Y,BU 520,ARM-3120,ARM-3020,ARM-3021, ARM-3022,ARM-3023,ARM-3080 Arm Blood Pressure Monitor, ARM-30G+, ARM-30M,ARM-30S,ARM-30T,ARM-HA101, BU 550 ARM-30A+,ARM-30G2, ARM-30Q,ARM-30E+,ARM-3010,ARM-3011,ARM-3012,ARM-3013,ARM-3110, ARM-3040,ARM-30V,ARM-30W,SBM 15 PRESSURE XS PRO, PRESSURE 9S PRO, XS Pro, 9S Pro Wrist Blood Pressure Monitor AOJ-35C JB9398, JB9510, BW 550, BW 750 connect

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	2025-05-13
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-12-22
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-05-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-02-21

Official Correspondent

Jack Wang

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

Shenzhen AOJ Medical Technology Co., Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009551875	Shenzhen AOJ Medical Technology 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 3020848330. Last updated year: 2026. Please use registration number 3020848330 when referencing this establishment in official correspondence.