Schiller

The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, percentage…

Registry build 21.09.26

The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, percentage of oxygen saturationin arterial blood (SpO2) and pulse rate in adult or adolescent patients during stress tests. The BP-200 plus can be used for patients of both sexes and all races.

98manufacturers in China registered for this device type
2catalogue numbers in this listing
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 Schiller
Listed by Schiller AG, Switzerland
FDA product code DXN
Device type System, Measurement, Blood-Pressure, Non-Invasive
Device class Class 2
Regulation 21 CFR 870.1130
Establishment Contract manufacturer, Private-label distributor, Manufacturer, Exporter
510(k) K063814
Record published 2023-03-01
Record revised 2025-02-21 (version 2)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries manufacturing date, serial number
Storage Handling environment temperature -10 to 50 °C; Storage environment temperature 5 to 50 °C; Handling environment atmospheric pressure 572 to 1050 KiloPascal; Handling environment humidity 10 to 95 % RH

Catalogue Numbers

Catalogue numbers for Schiller
Catalogue number Size Status
BP-200 plus In distribution
BP-200 plus 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
K063814 2007-03-07
K051368 2005-08-09

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