Data / Medical devices / Taiwan / Bomei Co., Ltd.
Bomei Co., Ltd.: FDA-registered device maker in Taoyuan City, Taiwan, 2 510(k) clearances
Bomei Co., Ltd. is registered with the FDA (registration 3012396434) in Taoyuan City, Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 8, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012396434
- Address
- 4F, No 1492-2, Chunrih Rd., Bianzhou Village, Taoyuan Dist., Taoyuan City 33051, Taiwan, Taoyuan City, Taiwan, 33051
- Owner or operator
- BOMEI CO., LTD. (10051191)
- Roles
- Manufacturer
- First device listed
- February 15, 2016
- Registered through
- 2026
- Brand names listed
- BOMEI Instrument ( Shaft And Handle)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 8, 2021 | K202278 | OBS Anchorage Screw, Biokey Anchorage Screw | OAT | Substantially Equivalent | Bomei Co, Ltd. | accessdata.fda.gov |
| February 9, 2016 | K152297 | OBS Anchorage Screw | OAT | Substantially Equivalent | Bomei Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Orthodontic
- All makers of Instruments, Dental Hand
- All makers of Accessories, Implant, Dental, Endosseous
Updated January 8, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.