Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017955445

FEI Number

3017955445

Entity Name

ZHEJIANG BIOREAR BIOTECHNOLOGY CO.LTD

City/State/Country

Jiaxing Zhejiang, CN

Establishment Address

No.1099 Xingye Road, Daqiao Town, Nanhu District, Jiaxing Zhejiang 314000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZHEJIANG BIOREAR BIOTECHNOLOGY CO.LTD (Owner Number: 10092326)

Owner / Operator Contact Address

No.1099 Xingye Road, Daqiao Town, Nanhu District, Jiaxing, CN-ZJ 314000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Deep well plate, Tip comb, PCR plate, PCR tube, Vial Cuvette Pipette tip Trough, Reagent bottle, Reagent strip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2024-12-24
JRI	Cuvette, Thermostated	Clinical Chemistry	Class 1	862.2050	2024-12-25
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2025-04-27
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2024-12-25

Official Correspondent

Xi Cheng

US Agent Details

Luis Lopez Business: QUAERO LIFE SCIENCE NORTH AMERICA INC. Email: luis.lopez@quaerolifeamerica.com Phone: (978) 8881059

Related Public Records

Same Entity

ZHEJIANG BIOREAR BIOTECHNOLOGY CO.LTD

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017955445. Last updated year: 2026. Please use registration number 3017955445 when referencing this establishment in official correspondence.