HOCHUEN MEDICAL SDN. BHD.

FDA Device Registration & Listing · SENAI Johor, MY · Registration 3038610665

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
3038610665
FEI Number
3038610665
Entity Name
HOCHUEN MEDICAL SDN. BHD.
City/State/Country
SENAI Johor, MY
Establishment Address
62 Jalan I-Park SAC 6, Taman Perindustrian I-Park SAC, SENAI Johor 81400, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Hochuen Medical Sdn. Bhd. (Owner Number: 10093449)
Owner / Operator Contact Address
62 Jalan I-Park SAC 6, Taman Perindustrian I-Park SAC, SENAI, MY-01 81400, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ePlex® Respiratory Pathogen (RP) Panel binx io CT/NG Assay and binx io CT/NG System REAL Sensor Bands Metrix COVID-19 Test Tasso+, Tasso mini Fever Scout™ Continuous Monitoring Thermometer Container

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification Microbiology Class 2 866.3332 2025-05-16
OOU Parainfluenza Multiplex Nucleic Acid Assay Microbiology Class 2 866.3980 2025-05-16
OZX Mycoplasma Pneumoniae Dna Assay System Microbiology Class 2 866.3980 2025-05-16
OZY Chlamydophila Pneumoniae Dna Assay System Microbiology Class 2 866.3980 2025-05-16
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2025-05-16
OEM Human Metapneumovirus (Hmpv) Rna Assay System Microbiology Class 2 866.3980 2025-05-16
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2025-05-16
OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay Microbiology Class 2 866.3980 2025-05-16
OTG Non-Sars Coronavirus Multiplex Nucleic Acid Assay Microbiology Class 2 866.3980 2025-05-16
OEP Influenza A Virus Subtype Differentiation Nucleic Acid Assay Microbiology Class 2 866.3980 2025-05-16
LSL Dna-Reagents, Neisseria Microbiology Class 2 866.3390 2025-05-16
MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia Microbiology Class 1 866.3120 2025-05-16
QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections Microbiology Class 2 866.3393 2025-05-16
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2025-05-16
IOD Components, Exercise Physical Medicine Class 1 890.5350 2025-05-16
QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown Class N N/A 2025-05-16
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2025-05-16
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-05-16
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2025-05-16

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 Sdn. Bhd.
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
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2018 Hologic, Inc 2
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Z-0042-2025 Luminex Molecular Diagnostics Inc 2
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Z-0004-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022 Abbott Molecular, Inc. N
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022 Abbott Molecular, Inc. N
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Similar Registrations

Registration Number Establishment Name Location
3013019728 Hochuen Medical Technology Co.,Ltd. Shenzhen Guangdong, CN
3002773840 BioFire Diagnostics, LLC Salt Lake City, UT, US
1528450 Ortho-Clinical Diagnostics, Inc. ATHENS, OH, US
3006028115 Luminex Corporation Northbrook, IL, US
2024800 Hologic, Inc. SAN DIEGO, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038610665. Last updated year: 2026. Please use registration number 3038610665 when referencing this establishment in official correspondence.
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