Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016635427

FEI Number

3016635427

Entity Name

Hangzhou Bioer Technology Co., Ltd

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

1192 Bin An Rd, Hi-tech (Binjiang) District, Hangzhou Zhejiang 310053, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Bioer Technology Co., Ltd. (Owner Number: 10076674)

Owner / Operator Contact Address

1192 BinAn Rd, Binjiang District, Hangzhou, CN-ZJ 310053, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222771

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2020-10-21
OUL	Thermocycler, Generic	Clinical Chemistry	Class 1	862.2310	2025-02-09
JRG	Block, Heating	Clinical Chemistry	Class 1	862.2050	2024-11-18
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	Class 2	866.2950	2024-07-03

Official Correspondent

Zhengwei MA

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Hangzhou Bioer Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016635427. Last updated year: 2026. Please use registration number 3016635427 when referencing this establishment in official correspondence.