Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007307467

FEI Number

3007307467

Entity Name

SHENYANG CANTA MEDICAL TECH. CO., LTD

City/State/Country

Shengyang Liaoning, CN

Establishment Address

NO. 2-1 PUYU ROAD, SHENBEI NEW DISTRICT, SHENYANG, LIAONING PROVINCE, CHINA, Shengyang Liaoning 110136, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenyang Canta Medical Tech. Co., Ltd (Owner Number: 10027198)

Owner / Operator Contact Address

No.2-1 Puyu Road, Shenbei New District, Shenyang, Liaoning Province, People's Republic of China, Shengyang, CN-LN 110136, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081508

PMA Number

N/A

All Registered Proprietary Names

HG5-W-NS Oxygen Concentrator HG5-WN-NS Oxygen Concentrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2008-10-12

Official Correspondent

Xiaobo Zhu

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Shenyang Canta Medical Tech. 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

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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 3007307467. Last updated year: 2026. Please use registration number 3007307467 when referencing this establishment in official correspondence.