Momcozy

The Device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that…

Registry build 21.09.26

The Device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast

40manufacturers in China registered for this device type
44catalogue numbers in this listing
11510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (28), Zhejiang (5), Hong Kong (2). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HGX
Manufacturer City Province Registered as Device types
Essentia Industries Ltd. Dong Guan Guangdong Contract manufacturer 31
Alleva Medical (D.G.) Ltd Dongguan Guangdong Contract manufacturer 13
Joytech Healthcare Co., Ltd. Hangzhou Zhejiang Contract manufacturer 9
JDI Electronics Factory Dongguan Guangdong Contract manufacturer 7
Guangdong Xinbao Electrical Appliances Holdings Co., Ltd. Foshan Guangdong Contract manufacturer 6
Jiangsu Xinbei Electrical Appliances Co., Ltd. Wuxi Jiangsu Contract manufacturer 6
Shenzhen Jingxintai Houseware Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Huizhou LVB Maternal AND Infant Supplies Co., Ltd. Huizhou Guangdong Contract manufacturer 3
Huizhou Sunwinon Electronics Co., Ltd. Huizhou Guangdong Contract manufacturer 3
Mastars Industries Co., Ltd. Guangdong Guangdong Contract manufacturer 3
Rrdonnelley Dongguan Guangdong Contract manufacturer 3
SFY Intelligent Technology (Suzhou) Co., Ltd. Kunshan Jiangsu Contract manufacturer 3

Showing 12 of 40. All 40 manufacturers in China registered for Pump, Breast, Powered

Record

Regulatory record for Momcozy
Listed by Shenzhen Root Innovation Technology Co., Ltd., China
FDA product code HGX
Device type Pump, Breast, Powered
Device class Class 2
Regulation 21 CFR 884.5160
Establishment Specification developer, Manufacturer
510(k) K223693
Record published 2023-10-22
Record revised 2026-01-21 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number
Packaging Carton method of 12, carton method of 18, carton method of 27, carton of 12, carton of 18, carton method of 16
Distribution end date 2027-01-01

Catalogue Numbers

Catalogue numbers for Momcozy
Catalogue number Size Per pack Status
M6, Gray D In distribution
S12 Pro, White, Double In distribution
BP380- Grey D 2 In distribution
BP420- Red 2 In distribution
S9 Pro-pink In distribution
BP334 In distribution
BP141 In distribution
M5-white pink In distribution
S12 Pro-white-D 2 In distribution
S12 Pro-white In distribution
M5-Purple-D 2 In distribution
BP223, M9 Gray-D In distribution
M6, Red In distribution
M6, Gray In distribution
M5-Ombre pinkD In distribution
BP223, M9 Red-D In distribution
BP223, M9 Gray In distribution
S9 Pro-purple-D 2 In distribution
M5-Grey In distribution
S12 Pro, Pink, Single In distribution
S12 Pro, Pink, Double In distribution
BP141 In distribution
M6, Red D In distribution
BP380- Red In distribution
S9 Pro-grey In distribution
M5-Purple In distribution
M5-Ombre pink In distribution
S12 Pro-Pink In distribution
S12 Pro-Pink-D 2 In distribution
M5-burgundy In distribution
BP223, M9 Red In distribution
S9 Pro-purple In distribution
BP380- Red D 2 In distribution
M5 In distribution
M5-Green In distribution
S9 Pro-grey-D 2 In distribution
M5-Grey-D 2 In distribution
M5-Green-D 2 In distribution
S12 Pro, White, Single In distribution
S9 Pro-pink-D 2 In distribution
BP380- Grey In distribution
M5-burgundy-D 2 In distribution
BP137 In distribution
S10 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Spectra Uzinmedicare Co., Ltd. 144
Freemie Dao Health 93
Ameda, Inc. Ameda, Inc. 72
Motif Medical Cimilre Co., Ltd. 47
Symmetrical Health, LLC Cimilre Co., Ltd. 28
Electric Breast Pump Ningbo Huiyoo Baby Products Co., Ltd. 28
Ameda® Cimilre Co., Ltd. 22
LVB Huizhou LVB Maternal & Infant Supplies Co., Ltd. 17
Vive Vive Health LLC 17
ViveCare Vive Health LLC 16
Stella Baby USA Cimilre Co., Ltd. 15
Unimom Unimom Co. 15

Showing 12 of 307. All products under Pump, Breast, Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K254254 2026-06-18
K260538 2026-06-17
K253914 2026-04-29
K254258 2026-04-08
K253946 2026-04-07
K253934 2026-03-09
K253283 2025-10-29
K251394 2025-09-08
K241680 2024-12-20
K243629 2024-12-20
K233880 2024-03-06

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer