Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013019728

FEI Number

3013019728

Entity Name

Hochuen Medical Technology Co.,Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Building 2,ChungKin lnd.Estate,Huaxing Road,Dalang,Longhua District, Shenzhen Guangdong 518109, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hochuen Medical Technology Co.,Ltd. (Owner Number: 10055509)

Owner / Operator Contact Address

Building 2,ChungKin lnd.Estate,Huaxing Road,Dalang,Longhua District, Shenzhen, CN-GD 518109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

disposable medical face shield ePlex® Respiratory Pathogen (RP) Panel Metrix COVID/Flu Test, Metrix Reader Container Tasso+, Tasso mini

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-26
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2017-12-18
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2017-12-18
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2017-12-18
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2017-12-18
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay	Microbiology	Class 2	866.3980	2017-12-18
OZY	Chlamydophila Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2017-12-18
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2017-12-18
OZX	Mycoplasma Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2017-12-18
OQW	2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification	Microbiology	Class 2	866.3332	2017-12-18
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2017-12-18
QLT	Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices	Unknown	Class N	N/A	2025-03-16
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2024-11-18
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-07-12

Official Correspondent

No official correspondent registered.

US Agent Details

Jessie Yao Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Hochuen Medical 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
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2025	Luminex Molecular Diagnostics Inc	2	NxTAG Respiratory Pathogen Panel, REF: I051C0447
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Z-0043-2025	Luminex Molecular Diagnostics Inc	N	NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013019728. Last updated year: 2026. Please use registration number 3013019728 when referencing this establishment in official correspondence.