FDA Registration
Active
🇨🇳 China
binx io CT/NG Assay and binx io CT/NG System
Reg #: 3013019728
·
FEI: 3013019728
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Hochuen Medical Technology Co.,Ltd.
- Registration Number
- 3013019728
- FEI Number
- 3013019728
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 2,ChungKin lnd.Estate,Huaxing Road,Dalang,Longhua District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K200533
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
US Agent
- Business Name
- MEDRIGHT TECH INC
- Contact Name
- Jessie Yao
- Address
- 6302 FORT HAMILTON PARKWAY, 1R
- City
- Brooklyn
- State
- NY
- ZIP
- 11219
- Country
- US
- [email protected]
- Phone
- 718 2169957
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2023-09-27 |
| 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 |
Proprietary Names
binx io CT/NG Assay and binx io CT/NG System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)