Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017356406

FEI Number

3017356406

Entity Name

GUANGZHOU LABSIM BIOTECH CO., LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Room 425-433,Building H6,No.39 Ruihe Road,Huangpu District, Guangzhou City, Guangdong Province, China, Guangzhou Guangdong 510700, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou Labsim Biotech Co., Ltd (Owner Number: 10072578)

Owner / Operator Contact Address

Room 425-433,Building H6, No.39 Ruihe Road Huangpu District,Guangzhou City,Guangdong Province.CHINA, Guangzhou, CN-GD 510700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Microscope slides Immunofluorescent Analyzer AFS2000A Fluorescence Immunoanalyzer AFS-1000 Multi-channel Immunofluorescent Analyzer (AFS2100S, AFS2100A, AFS2100B, AFS2100C, AFS2100D, AFS2100E) Immunofluorescence Analyzer (AFS2600); Fluorescent Immunoassay Analyzer (AFS3000B); Automatic Fluorescence Immunoassay AnalyzerAFS3000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2023-03-07
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2020-04-29

Official Correspondent

tianguo Xu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Guangzhou Labsim Biotech 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 3017356406. Last updated year: 2026. Please use registration number 3017356406 when referencing this establishment in official correspondence.