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“BOMEI" Dental Hand Instruments (Non-Sterile)
EUDAMEDClass I (EU MDR)
Ref BD2915-0
Identity
- Trade Name
- “BOMEI" Dental Hand Instruments (Non-Sterile) EUDAMED
- Device Name
- Dental Hand Instruments (Non-Sterile) EUDAMED
- Model / Reference
- BD2915-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873185764 EUDAMED
- Basic UDI-DI
- 471987318P01MT EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
“BOMEI" Dental Hand Instruments (Non-Sterile) by BOMEI Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987318P01MT | Class I | Active |
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Manufacturer
- Manufacturer
- BOMEI Co., Ltd
- EUDAMED SRN
- TW-MF-000013725
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED c03d8897-0bc7-441b-a346-5e8b68dff781 61 fields · synced Jul 9, 2026