Hangzhou Bioer Technology Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 6 device types, 21 products catalogued, 1 clearance.
Hangzhou Bioer Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Block, Heating, Thermocycler, Generic and 4 other device types. 21 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | Hangzhou Bioer Technology Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016635427 |
| FEI number | 3016635427 |
| DUNS | 545256935 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 杭州博日科技股份有限公司 |
|---|---|
| Unified social credit code | 913301007399478414 |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | 1192 Bin An Rd, Hi-tech (Binjiang) District |
| Postal code | 310053 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Block, Heating | Class 1 | ThermoShaker Mixing Block, ThermoCell Cooling&Heating Block, ThermoQ, ThermoCell Mixing Block | 2024 | 6 |
| Clinical Sample Concentrator | Class 1 | 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, SimplicityTM Dx Extraction Kit,EXT-DoR-MD32S,EXT-DoR-MD32P,EXT-DoR-MD100B, Automated Nucleic Acid Purification System and 2 more | 2020 | 27 |
| Culture Media, Non-Selective And Non-Differential | Class 1 | 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 | 2024 | 18 |
| Microbial Nucleic Acid Storage And Stabilization Device | Class 2 | Sample Preservative Fluid, BSC82X1-A1 | 2024 | 3 |
| Real Time Nucleic Acid Amplification System | Class 2 | 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 | 2020 | 15 |
| Thermocycler, Generic | Class 1 | Modular Thermal Cycler with Controller | 2025 | 5 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222771 | 2024-06-26 | QBD | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1995 |
|---|---|
| Employees | 1000 |
| Factory area | 26000 |
| Main products | Fluorescent quantitative PCR systems, Gene amplification instruments, Molecular diagnostic reagents, Laboratory consumables |
| Certifications | ISO 9001, ISO 13485, Class III medical device |
| Export markets | 150+ countries and regions |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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