FDA Registration
Active
🇨🇳 China
Hochuen Medical Technology Co.,Ltd.
Reg #: 3013019728
·
FEI: 3013019728
·
Expires 2026
Products
20
Proprietary Names
9
Establishment Types
3
Classifications
20
Registration Details
- Registration Name
- Hochuen Medical Technology Co.,Ltd.
- Registration Number
- 3013019728
- FEI Number
- 3013019728
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 2,ChungKin lnd.Estate,Huaxing Road,Dalang,Longhua District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Hochuen Medical Technology Co.,Ltd.
- Operator Number
- 10055509
- Address
- Building 2,ChungKin lnd.Estate,Huaxing Road,Dalang,Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518109
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-26 |
| Human Metapneumovirus (Hmpv) Rna Assay System | OEM | Class 2 | Microbiology | No | 2017-12-18 |
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | Class 2 | Microbiology | No | 2017-12-18 |
| Non-Sars Coronavirus Multiplex Nucleic Acid Assay | OTG | Class 2 | Microbiology | No | 2017-12-18 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2017-12-18 |
| Influenza A Virus Subtype Differentiation Nucleic Acid Assay | OEP | Class 2 | Microbiology | No | 2017-12-18 |
| Chlamydophila Pneumoniae Dna Assay System | OZY | Class 2 | Microbiology | No | 2017-12-18 |
| Parainfluenza Multiplex Nucleic Acid Assay | OOU | Class 2 | Microbiology | No | 2017-12-18 |
| Mycoplasma Pneumoniae Dna Assay System | OZX | Class 2 | Microbiology | No | 2017-12-18 |
| 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | OQW | Class 2 | Microbiology | No | 2017-12-18 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2017-12-18 |
| Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices | QLT | Class N | Unknown | No | 2025-03-16 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2024-11-18 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2023-07-12 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2023-02-21 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2019-12-22 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2023-09-27 |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2023-09-27 |
| Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | QEP | Class 2 | Microbiology | No | 2023-09-27 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-08-02 |
Proprietary Names
disposable medical face shield
ePlex® Respiratory Pathogen (RP) Panel
Metrix COVID/Flu Test, Metrix Reader
Container
Tasso+, Tasso mini
Metrix COVID-19 Test
REAL Sensor Bands
binx io CT/NG Assay and binx io CT/NG System
Fever Scout Continuous Monitoring Thermometer
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device