Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026986849

FEI Number

3026986849

Entity Name

FANSHENG TECHNOLOGY (GUANGDONG) CO., LTD .

City/State/Country

Zhongshan City Guangdong, CN

Establishment Address

4F-1, Building D, No.1 Xingyu Road, Jidong'er Community, Xiaolan Town, Zhongshan City Guangdong 528415, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FANSHENG TECHNOLOGY (GUANGDONG) CO., LTD . (Owner Number: 10089137)

Owner / Operator Contact Address

4F-1, Building D, No.1 Xingyu Road, Jidong'er Community, Xiaolan Town, Zhongshan City, CN-GD 528415, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Easy-Squeezy Silicone Bulb Syringe - 2 Tips(SGE046) Silicone Penguin Nasal Aspirator - Pro(SGE070) Silicone Penguin Nasal Aspirator(SGE042) Easy-Squeezy Silicone Bulb Syringe(SGE017) Easy-Squeezy Silicone Bulb Syringe - Pro(SGE069) Swan Neck Nasal Aspirator(SGE084) SensiCup - Frosted - 20ml - 2pcs(MHK172-C) SensiCup - Frosted - 25ml - 2pcs(MHK174-C) SensiCup - Frosted - 20ml - 1pc(MHK171-C) SensiCup - Frosted - 25ml - 1pc(MHK173-C) SqueezieDOSE Silicone Dispenser Set(MHK200) Penguin Dual Feeding Syringe Set(MHK206) SqueezieDOSE Silicone Dispenser(MHK161) Oral Feeding Syringe(MHK024) haakaa® Nasal Aspirator(2-in-1 NasalAspirator with Sprayer) Flexi Silicone Nipple Shields(MHK081) Silicone Nipple Shields(2pcs)(AMZ006) Breast Feeding Nipple Shield-Butterfly Shape(MHK038) Silicone Nipple Shields(2pcs)(AMZ009) Silicone Nipple Shields(2pcs)(AMZ006-L) Ultra-Thin Silicone Nipple Shields - M(MHK003-M) Breastfeeding Nipple Shield - Orthodontic Teat (Round Base)(MHK083) Breastfeeding Nipple Shield - Orthodontic Teat (Triangle Base)(MHK082) Ultra-Thin Silicone Nipple Shields - L(MHK003-L) Breastfeeding Nipple Shield - Round Base(MHK037) Petal Soft Silicone Milk Collectors - 2pcs(MHK236) Silicone Colostrum Collector Pack (pre-sterilised)-8pcs(MHK219) Ladybug Silicone Breast Milk Collector - 150ml(MHK087) Ladybug Silicone Breast Milk Collector - 40ml(MHK143) Silicone Colostrum Collector (pre-sterilised) - 2pcs(MHK142) Silicone Colostrum Collector Pack(pre-sterilised)- 6ml - 6pcs(MHK242) Silicone Colostrum Collector 50pc Bulk Pack (pre-sterilised) - 2ml(MHK239) Halo Breastmilk Collector & Steriliser Bag Combo - 90ml Halo(2pcs) + 1250ml Steriliser Bag (1pc)(MHK233) Silicone Measuring & Feeding Lidded Cup (pre-sterilised) - 25ml-2pcs(MHK229) Pump, Collect & Sterilise Combo - 75ml Shell + 75ml Ladybug + 750ml Steriliser Bag(MHK202) Shell Wearable Silicone Breast Pump - 75ml - 1pc(MHK182) Silicone Colostrum Collector (pre-sterilised) - 20ml - 2pcs(MHK158) Shell Pumps & Steriliser Bag Combo - 75ml Shell (2pcs) + Steriliser Bag - S (1pc)(MHK201) Multi-size Silicone Colostrum Collector Pack (pre-sterilised) - 20ml*1+4ml*4(MHK159) Multi-size Silicone Colostrum Collector Pack (pre-sterilised) - 20ml*2+4ml*4(MHK195) Silicone Colostrum Collector & Lidded Cup Pack (pre-sterilised) - 2ml - 6pcs(MHK224) Ladybug Silicone Breast Milk Collectors (40ml) - 2pcs(MHK144) Shell Wearable Silicone Breast Pumps - 120ml Pump (2pcs) + Storage Bag - Rust -L(MHK185-R) Silicone Colostrum Collector (pre-sterilised) - 20ml - 1pc(MHK157) Ladybug Silicone Breast Milk Collectors (75ml) - 2pcs(MHK100) Shell Pump & Ladybug Milk Collector Combo - 75ml Shell + 75ml Ladybug(MHK189) Ladybug Silicone Breast Milk Collectors (40ml) - 2pcs(MHK144-B) Silicone Colostrum Collector & Lidded Cup Pack (pre-sterilised)-6ml-6pcs(MHK241) Silicone Colostrum Collector & Lidded Cup Pack (pre-sterilised)-2ml-6pcs(MHK224) Silicone Colostrum Collector Feeding Pack (pre-sterilised) - 6pcs(MHK190) Ladybug Silicone Breast Milk Collector - 75ml(MHK084) Petal Soft Silicone Milk Collector - 1pc(MHK235) Shell Pump & Steriliser Bag Combo-75ml Shell (1pc) + 750ml Steriliser Bag (1pc) - Grey(MHK246-G) Shell Pump & Steriliser Bag Combo-75ml Shell (2pcs) + 750ml Steriliser Bag (1pc) - Frosted(MHK201-F) Shell Wearable Silicone Breast Pumps - 120ml - 2pcs(MHK185) Ladybug Silicone Breast Milk Collectors (150ml) - 2pcs(MHK088) Halo Silicone Breastmilk Collector - 90ml - 1pc(MHK232) Silicone Colostrum Collector Pack (pre-sterilised) - 6pcs(MHK149) Shell Pump & Steriliser Bag Combo - 75ml Shell (1pc) + 750ml Steriliser Bag(1pc) - Frosted(MHK246-F) Shell Wearable Silicone Breast Pump - 120ml - 1pc(MHK184) Silicone Colostrum Collector 50pc Bulk Pack (pre-sterilised) (MHK180) Silicone Colostrum Collector (pre-sterilised) - 1pc(MHK140) Shell Wearable Silicone Breast Pumps - 75ml - 2pcs(MHK183) Pump, Collect & Sterilise Combo-75ml Shell + 75ml Ladybug + 750ml Steriliser Bag - Lime(MHK201-LE) Silicone Colostrum Collector Pack (pre-sterilised) - 12pcs(MHK156) Colostrum Essentials Pack - 4ml Collector (6pcs) + 750ml Steriliser Bag + Ice Brick(MHK208) Ladybug Silicone Breast Milk Collectors (75ml) - 2pcs(MHK100-B) Silicone Colostrum Collector (pre-sterilised)-4pcs (MHK222) Shell Pump & Steriliser Bag Combo - 75ml Shell (1pc) + 750ml Steriliser Bag (1pc) - Lime(MHK246-LE) Electric Breast Pump Silicone Dinky Digits Palm Teether(TPS018) Rainbow Crown Teether(TPS026) Double Silicone Teethers Set(AMZ031) Newborn Silicone Dummy(TPS010) Silicone Palm Teether(BHK062) Silicone Ferris Wheel Teether(BHK056) Silicone Rainbow Teether Set(AMZ082)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2023-11-09
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2023-11-09
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2023-11-09
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2025-07-23
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2023-11-09
PWA	Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	Obstetrics/Gynecology	Class 1	884.5150	2023-11-09
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-12-30
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2023-11-09

Official Correspondent

Hongxiang Lai

US Agent Details

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

Related Public Records

Same Entity

FANSHENG TECHNOLOGY (GUANGDONG) 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
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

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.

Similar Registrations

Registration Number	Establishment Name	Location
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3013025177	Phillips-Medisize Healthcare (Suzhou) CO., LTD	Suzhou Jiangsu, CN
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US
3013188547	ORTA MEDICAL LTD	TZUR YIGAL Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026986849. Last updated year: 2026. Please use registration number 3026986849 when referencing this establishment in official correspondence.