DONGGUAN E-TEST TECHNOLOGY CO.,LTD

FDA Device Registration & Listing · Dongguan Guangdong, CN · Registration 3017896172

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
3017896172
FEI Number
3017896172
Entity Name
DONGGUAN E-TEST TECHNOLOGY CO.,LTD
City/State/Country
Dongguan Guangdong, CN
Establishment Address
Room 201, 301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan Guangdong 523570, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
DONGGUAN E-TEST TECHNOLOGY CO.,LTD (Owner Number: 10079208)
Owner / Operator Contact Address
Room 201, 301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan, CN-GD 523570, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K193624
PMA Number
N/A

All Registered Proprietary Names

Automatic Upper Arm Blood Pressure Monitor (Model: BA-836, BA-839, BA-840, BA-856, BPU311) Automatic Upper Arm Blood Pressure Monitor (Model: BA 845X, BA-847X, BA-849X, BA-851X, BA-852X, BA 855X, BA-835) Automatic Upper Arm Blood Pressure Monitor (Model: BA-831X, BA-832X, BA 833X, BA-837X, BA-838X, BA-842X, BA-843X) Digital Thermometer (Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) Automatic Upper Arm Blood Pressure Monitor (model: BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819, 1001e, MDS1001UE) Automatic Upper Arm Blood Pressure Monitor (model :BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813 Automatic Upper Arm Blood Pressure Monitor (model: MDS1001, MDS1001U, MDS1001UT, MDS1001CS) Automatic Upper Arm Blood Pressure Monitor (model: BA-832X) Automatic Upper Arm Blood Pressure Monitor (model: MDS4001, MDS4001LA, MDS4001LAT, MDS4001PLUS, MDS5001) Automatic Upper Arm Blood Pressure Monitor (model: BA-815, BA-816)

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 2025-09-16
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-11-24
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-11-24
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-11-24

Official Correspondent

Victor Wan

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

DONGGUAN E-TEST TECHNOLOGY CO.,LTD
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017896172. Last updated year: 2026. Please use registration number 3017896172 when referencing this establishment in official correspondence.
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