B.pure
Bpure Infused REG FEM Pads 10C
9manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| RFI Hygiene Limited | Shanghai | Shanghai | Contract manufacturer | 7 |
| Guangdong Kawada Sanitary Products Co., Ltd. Southern District Branch Company. | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Fujian Hui’an Hecheng Household Products Co., Ltd. | Quanzhou | Fujian | Manufacturer | 12 |
| Shanghai Shuxiao Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 6 |
| Zhejiang Shuxiao Personal Hygiene Products Co., Ltd. | Jiashan | Zhejiang | Manufacturer | 5 |
| Kunshan Yari Sanitary Products Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 4 |
| Hebei Yihoucheng Commodity Co., Ltd. | Baoding | Hebei | Manufacturer | 3 |
| Syncworks Company Limited | Hong Kong | Hong Kong | Exporter | 3 |
| Guangdong Bainuo Sanitary Product Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Fourstar Group, Hong Kong |
|---|---|
| FDA product code | HHL |
| Device type | Pad, Menstrual, Scented, Scented-Deodorized |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5425 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-02-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 64431638A | In distribution | |
| 64431638C | In distribution | |
| 64431638B | In distribution | |
| 64431638 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cosmea | W. Pelz GmbH & Co. KG | 3 |
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.