Manufacturer registered with FDA
Yiwu Kebon Healthcare Co., Ltd.
Yiwu, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 322 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Yiwu Kebon Healthcare 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 | Yiwu Kebon Healthcare Co., Ltd. | 1 device types | — | Below |
| European Union | EUDAMED | Registration holder | Yiwu Kebon Healthcare Co., Ltd. | 13 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Yiwu Kebon Healthcare Co., Ltd. | 9 | — | 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 Yiwu Kebon Healthcare 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 |
|---|---|---|---|---|
| Roll CottonEFN · Class 1 | — | Maker | — | 2023 |
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 |
|---|---|---|
| YIWU KEBON HEALTHCARE CO., LTD.FDA reg. 3030017177 | Yiwu Zhejiang, China | Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089004). 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.