Identity
- Trade Name
- iO bone Block EUDAMED
- Device Name
- iO bone Block EUDAMED
- Model / Reference
- BLK6612 EUDAMEDBLK6625 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490624190 EUDAMED08809490624206 EUDAMED
- Basic UDI-DI
- B-08809490624190 EUDAMEDB-08809490624206 EUDAMED
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy 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
iO bone Block 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-08809490624190 | Class III | Active |
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Manufacturer
- Manufacturer
- Chiyewon Co., LTD.
- EUDAMED SRN
- KR-MF-000022264
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 94989071-7e10-4db5-b747-6e8881e5c822 61 fields · synced Jul 10, 2026
- EUDAMED 0d63c23a-b7cd-4b88-b3ad-b3d5bcbb8966 61 fields · synced May 17, 2026