Identity
- Trade Name
- Biokey Anchorage screw EUDAMED
- Device Name
- Non Sterile Orthodontic Anchorage Screw EUDAMED
- Model / Reference
- FH EUDAMEDFH-2110-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873183821 EUDAMED
- Basic UDI-DI
- B-04719873183821 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
Biokey 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-04719873183821 | 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 482b792d-addd-47ba-b8a5-e5d1678750af 61 fields · synced May 23, 2026