DM Systems (Beijing) Co., Ltd.

Manufacturer and brand owner in Beijing, China. 1 device type, 4 products catalogued.

Registry build 21.09.26

DM Systems (Beijing) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Electrocardiograph, Ambulatory (Without Analysis). 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.

1device type
4products catalogued under its own name

Registration

FDA registration record for DM Systems (Beijing) Co., Ltd.
Registered name DM SYSTEMS (BEIJING) CO., LTD.
Status Registered
Registration expires 2026
Registration number 3008413470
FEI number 3008413470
DUNS 421115912
Establishment type Manufacturer

Chinese Registration

Chinese company register details for DM Systems (Beijing) Co., Ltd.
Chinese legal name 迪姆软件(北京)有限公司
Source export sales certificate, Beijing medical products administration

Location

Address of DM Systems (Beijing) Co., Ltd.
City Beijing
Province Beijing
Address Room 1102, No. 2 Bldg, No. 10 Baifuquan
Postal code 102200
Country China

What It Makes

Device types DM Systems (Beijing) Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Electrocardiograph, Ambulatory (Without Analysis) Class 2 Holter ECG recorder 2010 4

Own-Brand Listings

Devices catalogued by DM Systems (Beijing) Co., Ltd.
Product Code Catalogue numbers
DMS 300-4A Holter Recorder MWJ 1
DMS 300-3A Holter Recorder MWJ 1
DMS 300-2W Holter Recorder MWJ 1
DMS 300-4AL Holter Recorder MWJ 1

Clearances

No clearance names DM Systems (Beijing) Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming DM Systems (Beijing) Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K133014 2014-05-19 MWJ Special Diagnostic Monitoring Software
K062959 2006-10-16 MWJ Special Diagnostic Monitoring Software

From the Company

Published by the company on its own website, not by the FDA.

Information published by DM Systems (Beijing) Co., Ltd.
Main products Holter ECG systems, Resting ECG, Stress test ECG, Ambulatory blood pressure monitors

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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.

The manufacturer named here can complete this record.

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