Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008711096

FEI Number

3008711096

Entity Name

Polybell (Guangzhou) Limited

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

No. 50 West Street, XiHu Village, Renhe Town, Baiyun District, Guangzhou Guangdong 510470, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

POLYBELL (GUANGZHOU) LIMITED (Owner Number: 10042954)

Owner / Operator Contact Address

No. 50 West Street, XiHu Village, Renhe Town, Baiyun District, Guangzhou, CN-GD 510470, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Electric Breast Pump/ BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1128, H1129, H620, H705, H706 baby proof me

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	2026-06-14
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2019-12-20
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2013-01-14
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-11-16
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2016-09-12

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Sokolowski Business: QXNR Email: bob.qara@gmail.com Phone: (224) 5755577

Related Public Records

Same Entity

POLYBELL (GUANGZHOU) LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038613693	HONKWANG ELECTRIC (PHILIPPINES), INC	Binan City Laguna, PH

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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008711096. Last updated year: 2026. Please use registration number 3008711096 when referencing this establishment in official correspondence.