Registered with FDA
Changzhou Hualian Health Dressing Co.,Ltd.
Changzhou, 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
- 10130 registrations outside the US
- Establishments
- 1China
Registered in 10 markets
Where regulators' registries name Changzhou Hualian Health Dressing 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 | Lister | Changzhou Hualian Health Dressing Co.,Ltd. | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | CHANGZHOU HUALIAN HEALTH DRESSING CO., LTDACHANGZHOU HUALIAN HEALTH DRESSING CO. LTD · CHANGZHOU HUALIAN HEALTH DRESSING CO., LTD. | 65 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Changzhou Hualian Health Dressing Co Ltd | 14 | 2012–2024 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CHANGZHOU HUALIAN HEALTH DRESSING CO., LTD. | 14 | 2007–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Changzhou Hualian Health Dressing Co., Ltd. | 13 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CHANGZHOU HUALIAN HEALTH DRESSING CO. LTD.CHANGZHOU HUALIAN HEALTH DRESSING CO.LTD | 10 | 2012–2019 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Changzhou Hualian Health Dressing Co., Ltd. | 10 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Changzhou Hualian Health Dressing Co LtdChangzhou Hualian Health Dressing Co. Ltd. | 2 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Changzhou Hualian Health Dressing Co. Ltd | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CHANGZHOU HUALIAN HEALTH DRESSING CO., LTD. | 1 | 2009–2009 | 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 Hualian Health Dressing 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 | — | Lister | Cotton nose bleed plugs | 2025 |
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 HUALIAN HEALTH DRESSING CO.,LTD.FDA reg. 3003807757 | Changzhou Jiangsu, China | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029342). 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.