Ameda
Dual milk collection system
33manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (16), Zhejiang (8), Jiangsu (3). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd | Foshan | Guangdong | Contract manufacturer | 11 |
| Fansheng Technology (Guangdong) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 8 |
| Ningbo Longwell Baby Products Co Ltd | Ningbo | Zhejiang | Contract manufacturer | 6 |
| Hayco Industries (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Hayco Enterprises (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| SFY Intelligent Technology (Suzhou) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Solstice Electronic Technologies ( Dongguan) Limited | Dongguan | Guangdong | Contract manufacturer | 2 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Essentia Industries Ltd. | Dong Guan | Guangdong | Contract manufacturer | 31 |
| Amis (Xiamen) Cultural Creativity Co., Ltd. | Xiamen | Fujian | Manufacturer | 28 |
Showing 12 of 33. All 33 manufacturers in China registered for Pump, Breast, Non-Powered
Record
| Listed by | Ameda, Inc., United States |
|---|---|
| FDA product code | HGY |
| Device type | Pump, Breast, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 884.5150 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| True Protect | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gen. 2 Silicone Breast Pump & Flower Stopper Set – 100ml – Pea Green | Think Green Limited | 13 |
| Ameda, Inc. | Ameda, Inc. | 11 |
| Gen. 2 Silicone Breast Pump & Flower Stopper Set – 150ml – Lavender | Think Green Limited | 9 |
| Amplim | Amplim, LLC | 8 |
| Breast Pump | Ningbo Huiyoo Baby Products Co., Ltd. | 5 |
| Dr. Brown’s | Dr. Brown’s Company | 5 |
| Spectra | Uzinmedicare Co., Ltd. | 4 |
| Gen. 3 Multifunctional Silicone Breast Pump & Silicone Cap – 160ml – Peach Ring | Think Green Limited | 4 |
| Neotech Bridge® | Neotech Products, LLC | 3 |
| Gen. 1 Silicone Breast Pump & Cap Set – Flower Pattern – Grey | Think Green Limited | 3 |
| Gen. 1 Silicone Breast Pump & Flower Stopper Set – Purple | Think Green Limited | 2 |
| Bellema | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2 |
Showing 12 of 73. All products under Pump, Breast, Non-Powered
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-02-12 | Class II | Under Investigation by firm | Devices were not sterilized | 12 collection systems | 2017-07-21 |
| 2015-02-12 | Class II | Under Investigation by firm | Devices were not sterilized | 1763 | 2017-07-21 |
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.