FDA Registration
Active
🇨🇳 China
Hangzhou Bioer Technology Co., Ltd
Reg #: 3016635427
·
FEI: 3016635427
·
Expires 2026
Products
6
Proprietary Names
22
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- Hangzhou Bioer Technology Co., Ltd
- Registration Number
- 3016635427
- FEI Number
- 3016635427
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1192 Bin An Rd, Hi-tech (Binjiang) District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222771
Owner / Operator
- Firm Name
- Hangzhou Bioer Technology Co., Ltd.
- Operator Number
- 10076674
- Address
- 1192 BinAn Rd, Binjiang District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310053
- Country
- CN
- Correspondent
- Zhengwei MA
US Agent
- Business Name
- Shenzhen Joyantech Consulting Co., Ltd.
- Contact Name
- Thomas Tang
- Address
- 25 Hopewell Drive Stony Brook
- City
- Stony Brook
- State
- NY
- ZIP
- 11790
- Country
- US
- [email protected]
- Phone
- 631 7511103
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2020-10-21 |
| Thermocycler, Generic | OUL | Class 1 | Clinical Chemistry | No | 2025-02-09 |
| Block, Heating | JRG | Class 1 | Clinical Chemistry | No | 2024-11-18 |
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | Class 2 | Microbiology | No | 2024-07-03 |
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2024-04-03 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2020-12-01 |
Proprietary Names
QuantGene 9600 Fluorescent Quantitative Detection System; QuantGene 9600; Real Time PCR;
LineGene 9600 Plus Fluorescent Quantitative Detection System, LineGene 9600 Plus, Real Time PCR;
LineGene MiniS Fluorescent Quantitative Detection System
GeneExplorer Thermal Cycler
QuantFlex Fluorometer, QuantFlex 800
careSTART Q1 Amplifier
Modular Thermal Cycler with Controller
ThermoQ
ThermoCell Cooling&Heating Block
ThermoShaker Mixing Block
ThermoCell Mixing Block
Sample Preservative Fluid, BSC82X1-A1
Viral Transport Medium, BSC85X1-A2 BSC85X1-B2 BSC85X1-C2 BSC85S1 BSC85M1 BSC85L1
Viral Transport Medium, BSC85N1 BSC85X1-A BSC85X1-B BSC85X1-C BSC85N1-1 BSC85X1-A1 BSC85X1-B1 BSC85X1-C1 BSC85N1-2
GenePure 96 Nucleic Acid Purification System;GenePure Pro Nucleic Acid Purification System
MagaBio plus Virus DNA /RNA Purification Kit III
MagaBio plus Virus DNA/RNA Purification Kit II
MagaBio plus Virus RNA Purification Kit II
Automated Nucleic Acid Purification System
SimplicityTM Dx Extraction Kit,EXT-DoR-MD32S,EXT-DoR-MD32P,EXT-DoR-MD100B
SimplicityTM Dx Extraction System,EQP-ETR-MD32
GenePure Pro 16H Nucleic Acid Purification System
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device