SYSMED (CHINA) CO., LTD

FDA Device Registration & Listing · Shenyang Liaoning, CN · Registration 3010440667

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
3010440667
FEI Number
3010440667
Entity Name
SYSMED (CHINA) CO., LTD
City/State/Country
Shenyang Liaoning, CN
Establishment Address
No. 299, Baita Third Street, Hunnan District, Shenyang, Liaoning, 110169, China, Shenyang Liaoning 110169, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SYSMED (CHINA) CO., LTD (Owner Number: 10059312)
Owner / Operator Contact Address
No. 299, Baita Third Street, Hunnan District, Shenyang, CN-LN 110169, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K172234
PMA Number
N/A

All Registered Proprietary Names

Oxygen Concentrator Models M40 Oxygen Concentrator Models M30 Oxygen Concentrator Models M50 Oxygen Concentrator Models MQ30 Oxygen Concentrator Models MQ50

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2018-12-19

Official Correspondent

Liang Kong

US Agent Details

Anny Zhao Business: Hlongmed International Ltd. Email: usagent@hlongmed.com Phone: (503) 3344880

Related Public Records

Same Entity

SYSMED (CHINA) 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
K003939 Invacare Corp. VENTURE HOME FILL II, MODEL IOH 200 2001-03-21
K942357 Healthdyne, Inc. H-500 ALLIANCE OXYGEN CONCENTRATOR 1994-05-27
K042262 Sequal Technologies, Inc. INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 2004-09-10
K003472 Sequal Technologies, Inc. INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM 2001-06-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0038-2007 Sunrise Medical 2
DeVilbiss iFill Personal Oxygen Station model number 535D.

Similar Registrations

Registration Number Establishment Name Location
3004964590 AVOX SYSTEMS Lancaster, NY, US
3008841036 Oxus America, Inc. Orion Township, MI, US
3016809216 GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD. Guangzhou City Guangdong, CN
9611451 FISHER & PAYKEL HEALTHCARE, LTD. EAST TAMAKI Auckland, NZ
3013095415 VENTEC LIFE SYSTEMS, INC. Bothell, WA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010440667. Last updated year: 2026. Please use registration number 3010440667 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.