Cooceer Electronic Sphygmomanometers

The X8 electronic blood pressure monitor measures systolic and diastolic pressure and pulse rate using an upper-arm cuff. It is intended for adults, including people aged 18 to 21, with arm…

Registry build 21.09.26

The X8 electronic blood pressure monitor measures systolic and diastolic pressure and pulse rate using an upper-arm cuff. It is intended for adults, including people aged 18 to 21, with arm circumferences from 22 to 42 cm, in medical facilities or at home.

The monitor inflates and deflates the cuff and uses the oscillometric technique to determine the readings. A pressure sensor and microprocessor process cuff pressure changes, and an LCD displays the results. Users can choose blood pressure units in mmHg or kPa.

Listed Item

Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age.It can be used at medical facilities or at home.

Power and Memory

Four AAA batteries power the device. It stores up to 99 measurement sets for each of two users, can display the latest result and includes voice playback of readings.

98manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (67), Jiangsu (11), Zhejiang (6). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DXN
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Andon Health Co., Ltd. Tianjin Tianjin Contract manufacturer 22
Taizhou Rich Medical Products Co., Ltd. Taizhou Jiangsu Contract manufacturer 20
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Honsun (Nantong) Co., Ltd. Nantong Jiangsu Contract manufacturer 9
EMI (Dongguan) Asia Limited Dongguan Guangdong Contract manufacturer 9
Yahorng Dongguan Electronic Co Ltd Guangdong Guangdong Contract manufacturer 8
Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 7
Omron (Dalian) Co., Ltd. (Plant 1) Dalian Liaoning Contract manufacturer 7
Wuhan Strong Electronics Wuhan Hubei Contract manufacturer 6
Dongguan Polygreen Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Shenzhen Brav Electronic Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 3

Showing 12 of 98. All 98 manufacturers in China registered for System, Measurement, Blood-Pressure, Non-Invasive

Record

Regulatory record for Cooceer Electronic Sphygmomanometers
Listed by Jiangxi Aicare Medical Technology Co., Ltd., China
FDA product code DXN
Device type System, Measurement, Blood-Pressure, Non-Invasive
Device class Class 2
Regulation 21 CFR 870.1130
Establishment Manufacturer, Exporter
510(k) K221040
Record published 2023-08-31

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Cooceer Electronic Sphygmomanometers
Catalogue number Size Status
X8 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Baum W.A. Baum Co., Inc. 116
Alphamed Shenzhen Urion Technology Co., Ltd. 68
Electronic Blood Pressure Monitor Shenzhen Pango Electronic Co., Ltd. 59
Arm Type Automatic Blood Pressure Monitor Shenzhen Jiacom Technology Co., Ltd. 58
A&D Medical A&D Company, Ltd. 56
Diagnostix™ American Diagnostic Corp. 54
Lutech Lutech Industries 51
Veridian Veridian Healthcare 50
Hopkins Medical Products® Hopkins Uniform Company 49
Welch Allyn, Inc. Welch Allyn, Inc. 49
Merit Medical® Argon Critical Care Systems Singapore PTE. Ltd. 48
SunTech Suntech Medical, Inc. 46

Showing 12 of 1,292. All products under System, Measurement, Blood-Pressure, Non-Invasive

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K250185 2025-07-14
K221040 2022-08-31

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer