Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014328219

FEI Number

3014328219

Entity Name

ZHUHAI LIVZON DIAGNOSTICS INC.

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

No. 266, Tongchang Road, Xiangzhou District, Zhuhai Guangdong 519060, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zhuhai Livzon Diagnostics Inc. (Owner Number: 10066230)

Owner / Operator Contact Address

No. 266, Tongchang Road, Xiangzhou District, Zhuhai, CN-GD 519060, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PK CMV-PA System SERODIA-TP-PA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-05-10
MZE	Test, Donor, Cmv	Unknown	Class 2	N/A	2023-06-16
GMT	Antigens, Ha, Treponema Pallidum	Microbiology	Class 2	866.3830	2023-08-02

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Zhuhai Livzon Diagnostics Inc.

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 3014328219. Last updated year: 2026. Please use registration number 3014328219 when referencing this establishment in official correspondence.