Gel Pack
Gel Nipple Pads (900-00135)
15manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Fujian (4), Jiangsu (3).
| 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
| Listed by | Willow Innovations Inc., United States |
|---|---|
| FDA product code | NTC |
| Device type | Nursing Pad, Hydrogel |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5630 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-14 |
| Record revised | 2025-06-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GP2312 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Momcozy | Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. | 3 |
| Ameda ComfortGel Hydrogel Pads | Benq Materials Corporation | 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.