Identity
- Trade Name
- Bomei Anchorage screw EUDAMED
- Device Name
- Non Sterile Orthodontic Anchorage Screw EUDAMED
- Model / Reference
- BM EUDAMEDBM-2103-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873185368 EUDAMED
- Basic UDI-DI
- B-04719873185368 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bomei Anchorage screw by Bomei Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719873185368 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BOMEI Co., Ltd
- EUDAMED SRN
- TW-MF-000013725
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 0c480de3-769e-4e0e-ba32-327bc9e6d7cb 61 fields · synced May 23, 2026