Identity
- Trade Name
- Ti-oss® Block EUDAMED
- Device Name
- Ti-oss® Block EUDAMED
- Model / Reference
- BLK8812 EUDAMEDBLK8825 EUDAMEDBLK6612 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490620598 EUDAMED08809490620604 EUDAMED08809490620574 EUDAMED
- Basic UDI-DI
- B-08809490620598 EUDAMEDB-08809490620604 EUDAMEDB-08809490620574 EUDAMED
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
Ti-oss® 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-08809490620598 | 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 (3)
- EUDAMED 82a5839e-0313-4aa5-970b-f44acaf83516 61 fields · synced Jul 31, 2026
- EUDAMED dc633264-0e33-44e0-a31b-06eec954eb3b 61 fields · synced May 17, 2026
- EUDAMED e6d2d9db-af6d-4b7e-b82f-7d7312c6132c 61 fields · synced May 19, 2026