Sysmed (China) Co., Ltd.

Manufacturer and brand owner in Shenyang, Liaoning, China. 2 device types, 2 products catalogued, 2 clearances.

Registry build 21.09.26

Sysmed (China) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Generator, Oxygen, Portable, Ventilator, Non-Continuous (Respirator). 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.

2device types registered with the FDA
2products catalogued under its own name
2510(k) clearances

Registration

FDA registration record for Sysmed (China) Co., Ltd.
Registered name SYSMED (CHINA) CO., LTD
Status Registered
Registration expires 2026
Registration number 3010440667
FEI number 3010440667
DUNS 548237698
Establishment type Manufacturer

Location

Address of Sysmed (China) Co., Ltd.
City Shenyang
Province Liaoning
Address No. 299, Baita Third Street, Hunnan District
Postal code 110169
Country China

What It Makes

Device types Sysmed (China) Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Generator, Oxygen, Portable Class 2 Oxygen Concentrator Models M40, Oxygen Concentrator Models M30, Oxygen Concentrator Models M50, Oxygen Concentrator Models MQ50, Oxygen Concentrator Models MQ30 2018 22
Ventilator, Non-Continuous (Respirator) Class 2 ventilator, non-continuous (respirator) 2020 18

Own-Brand Listings

Devices catalogued by Sysmed (China) Co., Ltd.
Product Code Catalogue numbers
Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-Level BZD 8
Oxygen Concentrator CAW 2

Clearances

510(k) clearances naming Sysmed (China) Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K192177 2020-11-25 BZD Traditional This company
K172234 2018-06-01 CAW Traditional This company

From the Company

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

Information published by Sysmed (China) Co., Ltd.
Founded 2000
Main products Oxygen concentrator, Non-invasive ventilator
Certifications CE0123, ISO 13485, JGMP

Nearby Manufacturers

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.

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