Manufacturer registered with FDA
Bomei Co, Ltd.
Taoyuan City, Taiwan. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 1
- 510(k) clearances
- 22016–2021
- Markets registered in
- 6367 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Bomei 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 | Bomei Co, Ltd. | 2 clearances | 2016–2021 | Below |
| European Union | EUDAMED | Manufacturer | BOMEI Co.,Ltd | 352 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BOMEI CO., LTD. | 7 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | BOMEI CO., LTD. | 6 | 2017–2017 | Pure Global AI |
| Australia | TGA | Manufacturer | Bomei Co Ltd | 1 | 2025–2025 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Bomei Co., Ltd. | 1 | 2025–2025 | 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 Bomei 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 Endosseous ImplantOAT · Class 2 | — | Maker | — | 2016 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | — | 2016 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | BOMEI Instrument ( Shaft And Handle) | 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 |
|---|---|---|
| BOMEI CO., LTD.FDA reg. 3012396434 | Taoyuan City, Taiwan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051191). 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.