Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027841329

FEI Number

3027841329

Entity Name

SFY INTELLIGENT TECHNOLOGY (SUZHOU) CO.,LTD

City/State/Country

Kunshan Jiangsu, CN

Establishment Address

103# Huangnilou, Zhitang, Kunshan Jiangsu 215300, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SFY Intelligent Technology (Suzhou) Co.,Ltd (Owner Number: 10089185)

Owner / Operator Contact Address

103# Huangnilou, Zhitang, Kunshan, CN-JS 215300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PUMP, BREAST, NON-POWERED KIT Willow Generation 3 Breast Pump-Milk Bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHH	Breast Pump Kit	Obstetrics/Gynecology	Class 2	884.5160	2026-01-05
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-11-13

Official Correspondent

Dannis Guan

US Agent Details

Andy Smith Business: GRZAN GROUP INC. Email: info@grzan-ar.com Phone: (332) 2015192

Related Public Records

Same Entity

SFY Intelligent Technology (Suzhou) 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 3027841329. Last updated year: 2026. Please use registration number 3027841329 when referencing this establishment in official correspondence.