Manufacturer registered with FDA
Zhejiang Longmed Medical Technology Co., Ltd.
Huzhou, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 512 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Zhejiang Longmed Medical Technology 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 Longmed Medical Technology Co., Ltd. | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Zhejiang Longmed Medical Technology Co., LtdZhejiang Longmed Medical Technology Co., Ltd. · Zhejiang Longmed Medical Technology Co.,Ltd. | 5 | 2020–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ZHEJIANG LONGMED MEDICAL TECHNOLOGY CO., LTD. | 4 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Zhejiang Longmed Medical Technology Co., Ltd. | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Zhejiang Longmed Medical Technology 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 Zhejiang Longmed Medical Technology 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 Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Anti-snoring BracesLip TrainerMouth Guard, LubydPreformed Tooth PositionerTeeth Braces | 2022 |
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 LONGMED MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3015456954 | Huzhou Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060278). 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.