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Taiwan·TW-MF-000013725
Last updated September 17, 2026
What BOMEI Co.,Ltd makes
BOMEI Co., Ltd manufactures dental hand instruments, including non-sterile tools designed for use in dental procedures.
These devices are classified under EU regulations as Class I or Class IIb and are listed in the EUDAMED registry. The company is based in Taiwan.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does BOMEI Co., Ltd manufacture?
BOMEI Co., Ltd specializes in dental hand instruments, specifically non-sterile tools intended for use in dental procedures. These instruments are designed to assist in various dental treatments and procedures.
Where is BOMEI Co., Ltd based?
BOMEI Co., Ltd is based in Taiwan. The company’s location is relevant for understanding its regulatory context and manufacturing origins.
Which regulatory registries list BOMEI Co., Ltd’s devices?
BOMEI Co., Ltd’s devices are listed in the EUDAMED registry, which is the European Union’s database for medical devices. This registry tracks devices that have been authorized for placement on the EU market.
How are BOMEI Co., Ltd’s dental hand instruments classified under EU regulations?
Under EU regulations, BOMEI Co., Ltd’s dental hand instruments are classified as either Class I or Class IIb. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient safety, with Class IIb indicating a higher risk category requiring stricter regulatory scrutiny.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Taiwan
- Address
- 4F, No 1492-2, Chunrih Rd.,Taoyuan Dist., Taoyuan City , Taiwan
- Website
- www.biomech.com.tw/
- —
- —
- [email protected]
- Phone
- +886-3-355-4989 #303
- PRRC Contact
- Fred Li
- EUDAMED SRN
- TW-MF-000013725
- FDA FEI Number
- 3012396434
- DUNS Number
- —
Catalogue (229)
Page 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OBS Anchorage Screw | BD-2011-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2116-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2002-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2007-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2021-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2124-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2010-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2022-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2005-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2015-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2016-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2122-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2020-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2013-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2004-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2012-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2024-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2018-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2014-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2006-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2003-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2019-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2108-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2008-0 | FDA UDI | Class II | Active |
| OBS Anchorage Screw | BD-2023-0 | FDA UDI | Class II | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BM-2801-0 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BM2909-0 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BM2920-0 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BM-2809-0 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BM2925-0 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BD2918-0 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BR2904-0 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BM-2806-0 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BD2914-0 | EUDAMED | Class I | Active |
| OBS Anchorage Screw, Biokey Anchorage Screw | K202278 | FDA 510(k) | Class II | Active |
| Biokey Anchorage screw | BM-2118-4 | EUDAMED | Class IIb | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | AY2902-0 | EUDAMED | Class I | Active |
| Bomei Anchorage screw | BM-2103-4 | EUDAMED | Class IIb | Active |
| Biokey Anchorage screw | FH-2110-0 | EUDAMED | Class IIb | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BD2915-0 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BM2926-0 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | YM2901-1 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BD2911-0 | EUDAMED | Class I | Active |
| Biokey Anchorage screw | FH-2107-4 | EUDAMED | Class IIb | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BM2912-0 | EUDAMED | Class I | Active |
| Biokey Anchorage screw | AT-2104-4 | EUDAMED | Class IIb | Active |
| Biokey Anchorage screw | AT-2106-2 | EUDAMED | Class IIb | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BM2927-0 | EUDAMED | Class I | Active |
| “BOMEI" Dental Hand Instruments (Non-Sterile) | BM2913-0 | EUDAMED | Class I | Active |
| Biokey Anchorage screw | BM-2107-0 | EUDAMED | Class IIb | Active |
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