Ameda ComfortGel Hydrogel Pads

Soothes, cools and helps with tender sore nipples. Immediate relief on contact

Registry build 21.09.26
15manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (4), Fujian (4), Jiangsu (3).

Chinese manufacturers registered for FDA product code NTC
Manufacturer City Province Registered as Device types
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Hynaut Health Technology Co., Ltd. Qingdao Shandong Contract manufacturer 68
AID United International Co., Limited Shanghai Shanghai Specification developer 65
Yiwu Ori-Power Medtech Co., Ltd. Yiwu Zhejiang Contract manufacturer 46
H&K International Trade Limited (China) Jinhua Zhejiang Contract manufacturer 29
Wenzhou Zhusi Medical Supplies Co., Ltd. Wenzhou Zhejiang Contract manufacturer 27
Zhejiang Longterm Medical Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 26
Jiangsu Senwo Medical Technology Co., Ltd. Nantong Jiangsu Contract manufacturer 26
Shanghai Chuangshi Medical Technology (Group) Co., Ltd. Shanghai Shanghai Contract manufacturer 14
Fujian Hui’an Hecheng Household Products Co., Ltd. Quanzhou Fujian Manufacturer 12
Quanzhou V-Care Sanitary Products Co., Ltd. Quanzhou Fujian Manufacturer 10
Jiangsu Moen Industrial Co., Ltd. Suqian Jiangsu Manufacturer 8

Showing 12 of 15. All 15 manufacturers in China registered for Nursing Pad, Hydrogel

Record

Regulatory record for Ameda ComfortGel Hydrogel Pads
Listed by Benq Materials Corporation, Taiwan
FDA product code NTC
Device type Nursing Pad, Hydrogel
Device class Class 1
Regulation 21 CFR 880.5630
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2025-01-21

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Over the counter Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Ameda ComfortGel Hydrogel Pads
Catalogue number Size Per pack Status
17261M 2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Momcozy Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. 3
Gel Pack Willow Innovations Inc. 1
Instrapac Robinson Healthcare Limited 1

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