Manufacturer registered with FDA
Zhejiang Headway Medical Equipment Co., Ltd.
Hangzhou City, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6120 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Zhejiang Headway 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 | Zhejiang Headway Medical Equipment Co., Ltd. | 6 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Zhejiang Headway Medical Equipment Co., Ltd. | 113 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Zhejiang Headway Medical Equipment Co, Ltd. | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Zhejiang Headway Medical Equipment Co Ltd | 2 | 2026–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ZHEJIANG HEADWAY MEDICAL EQUIPMENT CO., LTD. | 1 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ZHEJIANG HEADWAY MEDICAL EQUIPMENT CO., LIMITED | 1 | 2026–2026 | 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 Zhejiang Headway 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 |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Archwires | 2016 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Buccal Tubes | 2016 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | micro screw driver handlesorthodontic toolsself ligating tools | 2024 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Bands | 2016 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Orthodontic Elastomeric Auxiliaries | 2016 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic Crimpable HooksOrthodontic Lingual ButtonsOrthodontic Lingual SheathsOrthodontic Metal BracketsOrthodontic Power Hooks | 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 |
|---|---|---|
| ZHEJIANG HEADWAY MEDICAL EQUIPMENT CO., LTD.FDA reg. 3013528406 | Hangzhou City Zhejiang, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053457). 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.