Identity
- Trade Name
- Octabone® EUDAMED
- Device Name
- Octabone® EUDAMED
- Model / Reference
- 10-0512 EUDAMED01-0512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490621847 EUDAMED08809490621816 EUDAMED
- Basic UDI-DI
- B-08809490621847 EUDAMEDB-08809490621816 EUDAMED
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Octabone® by Chiyewon Co., LTD. — Class III — 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-08809490621847 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chiyewon Co., LTD.
- EUDAMED SRN
- KR-MF-000022264
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 473533c9-5224-4f86-9180-f10ae3e35337 61 fields · synced Jul 18, 2026
- EUDAMED 8348072b-0f8d-4847-863e-ec38b117fafd 61 fields · synced May 19, 2026