Manufacturer registered with FDA
JOYTECH Healthcare Co Ltd
Hangzhou, China. Lists 1 dental device type with FDA across 2 registered establishments.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 16333 registrations outside the US
- Establishments
- 2China, Cambodia
Registered in 16 markets
Where regulators' registries name JOYTECH Healthcare 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 | JOYTECH Healthcare Co Ltd | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | JOYTECH HEALTHCARE CO., LTD,JOYTECH HEALTHCARE CO., LTD | 74 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | JOYTECH Healthcare Co., Ltd. | 68 | — | Pure Global AI |
| Australia | TGA | Manufacturer | JOYTECH Healthcare Co Ltd | 38 | 2014–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | JOYTECH HEALTHCARE CO., LTD. | 31 | 2020–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | JOYTECH HEALTHCARE CO., LTD.JOYTECH HEALTHCARE CO.,LTD | 20 | 2010–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | JOYTECH HEALTHCARE CO., LTD. | 17 | 2019–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Joytech Healthcare Co., Ltd.JOYTECH Healthcare Co., Ltd. · JOYTECH HEALTHCARE CO.,LTD · +2 | 17 | 2013–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | JOYTECH Healthcare Co., Ltd.JOYTECH Healthcare Co. Ltd. · JOYTECH HEALTHCARE CO. LTD · +2 | 14 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Joytech Healthcare Co., Ltd.JOYTECH Healthcare Co., Ltd. | 14 | 2011–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | JOYTECH Healthcare Co., Ltd. | 12 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | JOYTECH HEALTHCARE CO.,LTDJOYTECH Healthcare Co., Ltd | 11 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | JOYTECH Healthcare Co., Ltd. | 9 | 2024–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | JOYTECH Healthcare Co., Ltd.JOYTECH HEALTHCARE Co.. Ltd. · Joytech Healthcare Co., Ltd. | 4 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | JOYTECH Healthcare Co., Ltd. | 2 | 2025–2025 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | JOYTECH Healthcare Co., Ltd | 2 | 2022–2022 | 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 JOYTECH Healthcare 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 |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | SEJOY Oral Irrigator | 2024 |
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 |
|---|---|---|
| JOYTECH HEALTHCARE CO., LTD.FDA reg. 3030671608 | Hangzhou Zhejiang, China | Foreign exporter, Manufacturer |
| RENS MEDCARE (CAMBODIA) CO.,LTD.FDA reg. 3024790242 | Sihanouk Preah Sihanouk, Cambodia | Foreign exporter, Manufacturer |
Other names on FDA records
Rens Medcare (Cambodia) Co.,ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054061). 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.