Identity
- Trade Name
- Biokey Anchorage screw EUDAMED
- Device Name
- Non Sterile Orthodontic Anchorage Screw EUDAMED
- Model / Reference
- FH EUDAMEDFH-2124-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873184040 EUDAMED
- Basic UDI-DI
- B-04719873184040 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
The Biokey Anchorage screw is a non-sterile orthodontic anchorage device used in dental implants, particularly for mandibular and maxillary positions. Its unique design features a reinforced anchor point with an internal counterthread for improved stability and resistance to rotation.
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-04719873184040 | Class IIb | 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 97d99c50-b047-415d-ab8c-52a85918af76 61 fields · synced Jul 1, 2026