Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013513831

FEI Number

3013513831

Entity Name

INFINIQUE ELECTRONIC (DONGGUAN) CO. LTD.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 301, Building 4, No. 29, Bihu Road, Fenggang Town, Dongguan Guangdong 523690, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

INFINIQUE ELECTRONIC (DONGGUAN) CO. LTD. (Owner Number: 10053353)

Owner / Operator Contact Address

Room 301, Building 4, No. 29, Bihu Road, Fenggang Town,, Dongguan, CN-GD 523690, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

N/A N/A N/A N/A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2022-03-04
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2022-03-02
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2019-11-28
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2017-01-03

Official Correspondent

No official correspondent registered.

US Agent Details

Brent Eikanas Business: CLEBAE Infinique Tooling Molding Email: mljyangguang@msn.com Phone: (408) 4256063

Related Public Records

Same Entity

INFINIQUE ELECTRONIC (DONGGUAN) 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
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10

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1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013513831. Last updated year: 2026. Please use registration number 3013513831 when referencing this establishment in official correspondence.