Identity
- Trade Name
- Biongraft EUDAMED
- Device Name
- Biongraft® PLDLLA+TCP 30 Interference Screws Ø 10mm x 30mm EUDAMED
- Model / Reference
- SCRW-BIPT30IS1030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681781337046 EUDAMED
- Basic UDI-DI
- B-08681781337046 EUDAMED
- EMDN Code
- P09120605 INTERFERENCE SCREWS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Category: Tendon/ligament bone anchor, non-bioabsorbable
Biongraft by Bonegraft Biomaterials Co. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08681781337046 | Class III | Active |
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Manufacturer
- Manufacturer
- Bonegraft Biomaterials Co.
- EUDAMED SRN
- TR-MF-000015715
Sources (1)
- EUDAMED af417b54-eb0c-475a-b4c7-9e3fc16bcea8 61 fields · synced Jun 19, 2026