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"BOMEI" Dental Hand Instruments(Non-Sterile)
EUDAMEDClass I (EU MDR)
Ref BM2905-1Ref BM2906-0Ref BD2920-0
Identity
- Trade Name
- "BOMEI" Dental Hand Instruments(Non-Sterile) EUDAMED“BOMEI" Dental Hand Instruments (Non-Sterile) EUDAMED
- Device Name
- Dental Hand Instruments (Non-Sterile) EUDAMED
- Model / Reference
- BM2905-1 EUDAMEDBM2906-0 EUDAMEDBD2920-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873181469 EUDAMED04719873181476 EUDAMED04719897675807 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 (3)
- EUDAMED c4a3d434-9880-4fb1-ba02-bd8e4fa43e79 61 fields · synced Oct 6, 2026
- EUDAMED 8af1b8f1-5fbf-40c2-8679-2383a474796d 61 fields · synced May 17, 2026
- EUDAMED 72b50e2b-23d3-42cf-a71e-fb77bc657aca 61 fields · synced May 18, 2026