Data / Medical devices / China / Hangzhou Bioer Technology Co., Ltd
Hangzhou Bioer Technology Co., Ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 1 510(k) clearance
Hangzhou Bioer Technology Co., Ltd is registered with the FDA (registration 3016635427) in Hangzhou Zhejiang, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016635427
- Address
- 1192 Bin An Rd, Hi-tech (Binjiang) District, Hangzhou Zhejiang, China, 310053
- Owner or operator
- Hangzhou Bioer Technology Co., Ltd. (10076674)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 21, 2020
- Registered through
- 2026
- Brand names listed
- Automated Nucleic Acid Purification System, GeneExplorer Thermal Cycler, GenePure 96 Nucleic Acid Purification System;GenePure Pro Nucleic Acid Purification System, GenePure Pro 16H Nucleic Acid Purification System, LineGene 9600 Plus Fluorescent Quantitative Detection System, LineGene 9600 Plus, Real Time PCR;, LineGene MiniS Fluorescent Quantitative Detection System, MagaBio plus Virus DNA /RNA Purification Kit III, MagaBio plus Virus DNA/RNA Purification Kit II and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Block, Heating | JRG | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Clinical Sample Concentrator | JJH | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Manufacturer | accessdata.fda.gov |
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | 2 | Manufacturer | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Thermocycler, Generic | OUL | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 26, 2024 | K222771 | Sample Preservative Fluid | QBD | Substantially Equivalent | Hangzhou Bioer Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Thermocycler, Generic
- All makers of Real Time Nucleic Acid Amplification System
- All makers of Clinical Sample Concentrator
- All makers of Block, Heating
- All makers of Microbial Nucleic Acid Storage And Stabilization Device
- All makers of Culture Media, Non-Selective And Non-Differential
Updated June 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.