SHENZHEN HARVEYMED TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3033814505

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
3033814505
FEI Number
3033814505
Entity Name
SHENZHEN HARVEYMED TECHNOLOGY CO., LTD.
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
B203 Weike science and technology building, No. 20, Gaoxin West Road, Dongzhou community, Guangming Street, Guangming District, Shenzhen Guangdong 518083, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shenzhen HarveyMed Technology Co., Ltd. (Owner Number: 10091599)
Owner / Operator Contact Address
B203 Weike science and technology building, No. 20, Gaoxin West Road, Dongzhou community,, Guangming Street, Guangming District, Shenzhen, CN-GD 518083, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

HarveyMed, V series portable oxygen concentrator, Model: V5, V5C, V6, V6C

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2025-12-25

Official Correspondent

Zhiang Huang

US Agent Details

Thomas Tang Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Shenzhen HarveyMed Technology 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033814505. Last updated year: 2026. Please use registration number 3033814505 when referencing this establishment in official correspondence.
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