Manufacturer registered with FDA
Hangzhou DTC Medical Apparatus Co., Ltd
Hangzhou, China. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 11410 registrations outside the US
- Establishments
- 1China
Registered in 11 markets
Where regulators' registries name Hangzhou DTC Medical Apparatus 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 | Hangzhou DTC Medical Apparatus Co., Ltd | 10 device types | — | Below |
| Colombia | INVIMA | Manufacturer | HANGZHOU DTC MEDICAL APPARATUS CO., LTDHANGZHOU DTC MEDICAL APPARATUS CO.,LTD | 334 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Hangzhou DTC Medical Apparatus Co., Ltd. | 22 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | HANGZHOU DTC MEDICAL APPARATUS CO., LTDHANGZHOU DTC MEDICAL APPARATUS CO. LTD. | 18 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Hangzhou DTC Medical Apparatus Co.,Ltd | 13 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Hangzhou DTC Medical Apparatus Co Ltd | 9 | 2021–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HANGZHOU DTC MEDICAL APPARATUS CO., LTD | 5 | 2020–2020 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Hangzhou DTC Medical Apparatus Co., LtdHangzhou DTC Medical Apparatus Co.,Ltd | 4 | 2018–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HANGZHOU DTC MEDICAL APPARATUS CO., LTD. | 3 | 2022–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Hangzhou DTC Medical Apparatus,co.,ltd | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Hangzhou DTC Medical Apparatus CO., Ltd | 1 | 2021–2021 | 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 Hangzhou DTC Medical Apparatus 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 Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Expansion Screw;DTC;Orthodontics | 2015 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Dental Tubes;Buccal Tubes;DTC;Orthodontics | 2015 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Dental Mirror;DTC;Orthodontics | 2016 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Dental Bands;DTC;Orthodontics | 2015 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Arch Wires;DTC;Orthodontics | 2015 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | DTC;Orthodontics | 2015 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | Dental Brackets;DTC;Orthodontics | 2015 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Dental Brackets;DTC;Orthodontics | 2015 |
| Preformed CrownELZ · Class 1 | — | Maker | Stainless Steel crown | 2026 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Metal Pliers;DTC;Orthodontics | 2015 |
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 |
|---|---|---|
| HANGZHOU DTC MEDICAL APPARATUS CO., LTDFDA reg. 3009955691 | Hangzhou Zhejiang, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049604). 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.