Manufacturer registered with FDA
Changzhou Shumei Plastic Product Co.,Ltd.
Changzhou, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Changzhou Shumei Plastic Product Co.,Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Changzhou Shumei Plastic Product Co.,Ltd. | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | CHANGZHOU SHUMEI PLASTIC PRODUCT CO. LTDA | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Changzhou Shumei Plastic Product Co.,Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | dental flossdental flosspick | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CHANGZHOU SHUMEI PLASTIC PRODUCT CO.,LTD.FDA reg. 3012762648 | Changzhou City Jiangsu, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051964). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.