Identity
- Trade Name
- iO bone Block EUDAMED
- Device Name
- iO bone Block EUDAMED
- Model / Reference
- BLK8812 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490624213 EUDAMED
- Basic UDI-DI
- B-08809490624213 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-08809490624213 | 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 (1)
- EUDAMED 1c905f1b-ad57-4fa3-bd45-b6fd1765f679 61 fields · synced Jun 19, 2026