Manufacturer registered with FDA
Danyang New Hope Medical Equipment Co., Ltd
Danyang, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 435 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Danyang New Hope Medical Equipment 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 | Danyang New Hope Medical Equipment Co., Ltd | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Danyang New Hope Medical Equipment Co., Ltd. | 32 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Danyang New Hope Medical Equipment Co Ltd | 2 | 2022–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DANYANG NEW HOPE MEDICAL EQUIPMENT CO.,LTD | 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 Danyang New Hope Medical Equipment 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 Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Dental Chair | 2019 |
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 |
|---|---|---|
| DANYANG NEW HOPE MEDICAL EQUIPMENT CO., LTDFDA reg. 3011659880 | Danyang Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049037). 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.