Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011649813

FEI Number

3011649813

Entity Name

HUACHENYANG(SHENZHEN)TECHNOLOGY CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

8, Bldg 4, No.128 Shangnan East Rd.,, Huangpu Community, XingiaoSt., Bao'an, Shenzhen Guangdong 518125, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Huachenyang(Shenzhen)Technology Company Ltd (Owner Number: 10048986)

Owner / Operator Contact Address

8F, Bldg 4,128# Shangnan East Rd, Bao'an, Shenzhen, CN-GD 518125, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Culture Swab, Stuart medium, Amies medium, Cary Blair medium, Plastic Tube Preservation Solution, Sample Collection kit, Saliva Collection kit, Normal Saline iClean Viral Transport System(VTM Kit), iClean Viral Transport System(UTM Kit), Viral Transport Media Kit(VTM Kit), VTM kit,Viral Transport Medium iClean Viral Transport System (VTM-RT kit), Plastic Tube Plastic Tube, Swabs with Empty Tube, Dry Swab Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2020-05-01
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2018-12-30
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-01-08
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2022-08-31
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2017-06-29
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2020-05-01

Official Correspondent

Oliver Hou

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Huachenyang(Shenzhen)Technology Company 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
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18

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3017170972	SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.	Shenzhen Guangdong, CN
9615755	BIOMERIEUX FRANCE	CRAPONNE Rhone, FR
1054241	DeRoyal Industries, Inc.	NEW TAZEWELL, TN, US
1930987	LABONE, INC.	LENEXA, KS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011649813. Last updated year: 2026. Please use registration number 3011649813 when referencing this establishment in official correspondence.