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“BOMEI" Dental Hand Instruments (Non-Sterile)
EUDAMEDFDA UDIClass I (EU MDR)
Ref BD2906-0
Identity
- Trade Name
- “BOMEI" Dental Hand Instruments (Non-Sterile) EUDAMEDOBS HANDLE / Black FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Dental Hand Instruments (Non-Sterile) EUDAMEDOperated with the shaft for screw insertion and removal. Material: AL6061/SUS304 FDA UDI
- Model / Reference
- BD2906-0 EUDAMEDFDA UDI
- Description
- Operated with the shaft for screw insertion and removal. Material: AL6061/SUS304 FDA UDI
Identifiers
- Catalog Number
- BD2906-0 FDA UDI
- Primary DI / UDI-DI
- 04719873180493 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987318P01MT EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
“BOMEI" Dental Hand Instruments (Non-Sterile) by BOMEI Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987318P01MT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BOMEI Co., Ltd
- EUDAMED SRN
- TW-MF-000013725
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED b9c92f68-4cee-4b95-89ed-fc67c0dfd5d5 61 fields · synced Jun 19, 2026
- FDA UDI 03aa6877-7399-4bc1-9f50-db0b9b8bb429 34 fields · synced May 30, 2026