Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014759586

FEI Number

3014759586

Entity Name

NINGBO HUIYOO BABY PRODUCTS CO., LTD.

City/State/Country

Cixi Zhejiang, CN

Establishment Address

523# CiZhang Road, Zhangqi Industrial Area, Cixi Zhejiang 315313, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NINGBO HUIYOO BABY PRODUCTS CO., LTD. (Owner Number: 10061807)

Owner / Operator Contact Address

523# CiZhang Road, Zhangqi Industrial Area, 45-1# Bei Yi Huan Road, Zhang qi Town, Cixi, CN-ZJ 315313, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191802

PMA Number

N/A

All Registered Proprietary Names

BLA-8017-1,BLA-8017,BLA8017,BLA8012,BLA8013 BLA8019,BLA8020,BLA8021,BLA8022,BLA8023,BLA8024 BLA-8015,BLA-8015-02,BLA8015-02 BLA8040,BLA8041,BLA8042,BLA8043,BLA8040-2,BLA8042-2 BLA8034,BLA8035,BLA8037,BLA8038,BLA8039 RBX8029,RBX8030,RBX8028,RBX8031,RBX8037 RBX8015,RBX8020,RBX8021

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2019-11-20
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2020-01-16

Official Correspondent

Xiaoping Liu

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

NINGBO HUIYOO BABY PRODUCTS 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 3014759586. Last updated year: 2026. Please use registration number 3014759586 when referencing this establishment in official correspondence.