PureClarity™
PureClarity™ Purification Filter - Installation Kit
14manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Parkell, Inc., 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-12-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D718 | In distribution | |
| D719 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HistoSonics | Histosonics, Inc | 2 |
| WaterSoft 0-30 | IBT Scientific | 1 |
| WaterSoft | IBT Scientific | 1 |
| Water Hardness Test Strip | Reprocessing Products Corp | 1 |
| Alinity | Abbott Laboratories | 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.