Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007491602

FEI Number

3007491602

Entity Name

Spartronics Viet Nam Co., LTD

City/State/Country

Ho Chi Minh, VN

Establishment Address

Lot A, Nam Tan Uyen Industrial Park, Tan Hiep Ward, Ho Chi Minh 70000, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Spartronics Viet Nam Co., LTD (Owner Number: 10041484)

Owner / Operator Contact Address

Lot A, Nam Tan Uyen IP, Tan Hiep Ward, Ho Chi Minh, VN-SG 70000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ameda breast pump

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2012-07-30

Official Correspondent

No official correspondent registered.

US Agent Details

Calzolaio Audrey Email: audrey.calzolaio@spartronics.com Phone: (570) 3266591

Related Public Records

Same Entity

Spartronics Viet Nam 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007491602. Last updated year: 2026. Please use registration number 3007491602 when referencing this establishment in official correspondence.