Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014655875

FEI Number

3014655875

Entity Name

GENOBIO PHARMACEUTICAL CO., LTD.

City/State/Country

Tianjin, CN

Establishment Address

2-1,2,3-101,No.2 Zone, Binlv Industrial Park,Binhai Tourism Area,Binhai New Area, Tianjin 300480, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Genobio Pharmaceutical Co., Ltd. (Owner Number: 10066045)

Owner / Operator Contact Address

2-1,2,3-101,No.2 Zone, Binlv Industrial Park,Binhai Tourism Area,Binhai New Area, Tianjin, CN-TJ 300480, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GMD	Antisera, Latex Agglutination, Cryptococcus Neoformans	Microbiology	Class 2	866.3165	2020-03-31

Official Correspondent

Zixi He

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Genobio Pharmaceutical 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 3014655875. Last updated year: 2026. Please use registration number 3014655875 when referencing this establishment in official correspondence.