Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010610113

FEI Number

3010610113

Entity Name

SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

No.23 Jinxiu East Road, Pingshan District, Shenzhen Guangdong 518122, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen New Industries Biomedical Engineering Co.,Ltd (Owner Number: 10049797)

Owner / Operator Contact Address

No. 23, Jinxiu East Road, Pingshan District, Shenzhen, CN-GD 518122, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MAGLUMI 2019-nCoV IgM MAGLUMI 2019-nCoV IgG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-03-25

Official Correspondent

Xiaoli Wang

US Agent Details

Joe Xia Business: LSI International Email: jxia@lsi-consulting.org Phone: (240) 5057880

Related Public Records

Same Entity

Shenzhen New Industries Biomedical Engineering 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 3010610113. Last updated year: 2026. Please use registration number 3010610113 when referencing this establishment in official correspondence.