Manufacturer registered with FDA
Dongyang City Yonoel Outdoor Products Co.,Ltd
Dongyang, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 29 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Dongyang City Yonoel Outdoor Products 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 | Dongyang City Yonoel Outdoor Products Co.,Ltd | 2 device types | — | Below |
| European Union | EUDAMED | Registration holder | Dongyang City Yonoel Outdoor Products 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 Dongyang City Yonoel Outdoor Products 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 | — | 2021 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | — | 2021 |
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 |
|---|---|---|
| DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTDFDA reg. 3021282544 | Dongyang Zhejiang, China | Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083407). 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.