Alinity
Alinity h-series WATER PURIFICATION SYSTEM
14manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), Shandong (3), Jilin (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| SP Moulding (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Guangzhou Huiming Fibre Products Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 11 |
| Huizhou Hizorion Tech Co., Ltd. | Huizhou | Guangdong | Manufacturer | 11 |
Showing 12 of 14. All 14 manufacturers in China registered for Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | JRS |
| Device type | Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-11-16 |
| Record revised | 2026-07-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09P7101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PureClarity™ | Parkell, Inc. | 2 |
| HistoSonics | Histosonics, Inc | 2 |
| WaterSoft 0-30 | IBT Scientific | 1 |
| WaterSoft | IBT Scientific | 1 |
| Water Hardness Test Strip | Reprocessing Products Corp | 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.