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Alpha-Bio Tec™ xenobone Block
EUDAMEDClass III (EU MDR)
Ref BLK6625Ref BLK8812Ref BLK6612Ref BLK8825
Identity
- Trade Name
- Alpha-Bio Tec™ xenobone Block EUDAMED
- Device Name
- Alpha-Bio Tec™ xenobone Block EUDAMED
- Model / Reference
- BLK6625 EUDAMEDBLK8812 EUDAMEDBLK6612 EUDAMEDBLK8825 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490623155 EUDAMED08809490623162 EUDAMED08809490623148 EUDAMED08809490623179 EUDAMED
- Basic UDI-DI
- B-08809490623155 EUDAMEDB-08809490623162 EUDAMEDB-08809490623148 EUDAMEDB-08809490623179 EUDAMED
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands 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
Alpha-Bio Tec™ xenobone 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-08809490623155 | 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 (4)
- EUDAMED 4e7d184a-e345-45d7-a45a-97f87b3ed0c4 61 fields · synced Sep 17, 2026
- EUDAMED 1ade6cfc-d6ca-4261-8950-2193c18abb57 61 fields · synced May 17, 2026
- EUDAMED b7b592bb-1371-4c78-9032-83d810150338 61 fields · synced May 18, 2026
- EUDAMED 0d94a151-dbf3-4b45-ac1b-6b0d023de303 61 fields · synced May 19, 2026