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Alpha-Bio Tec™ xenobone
EUDAMEDClass III (EU MDR)
Ref 01-1217Ref 20-1217Ref 05-0512Ref 05-1217Ref 05-0210Ref 25-1217Ref 10-0512Ref 01-0512
Identity
- Trade Name
- Alpha-Bio Tec™ xenobone EUDAMED
- Device Name
- Alpha-Bio Tec™ xenobone EUDAMED
- Model / Reference
- 01-1217 EUDAMED20-1217 EUDAMED05-0512 EUDAMED05-1217 EUDAMED05-0210 EUDAMED25-1217 EUDAMED10-0512 EUDAMED01-0512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490623094 EUDAMED08809490623131 EUDAMED08809490623063 EUDAMED08809490623117 EUDAMED08809490623018 EUDAMED08809490623100 EUDAMED08809490623070 EUDAMED08809490623049 EUDAMED
- Basic UDI-DI
- B-08809490623094 EUDAMEDB-08809490623131 EUDAMEDB-08809490623063 EUDAMEDB-08809490623117 EUDAMEDB-08809490623018 EUDAMEDB-08809490623100 EUDAMEDB-08809490623070 EUDAMEDB-08809490623049 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 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-08809490623094 | 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 (8)
- EUDAMED 406932f7-76df-4999-a225-f03c9196eee9 61 fields · synced Aug 4, 2026
- EUDAMED a1be241c-e84e-4f96-9626-d776e0166bd0 61 fields · synced May 16, 2026
- EUDAMED d56ed91e-4dec-45c0-b41f-7c716997fc88 61 fields · synced May 16, 2026
- EUDAMED 5907762f-9fbb-40f8-bc78-0ef9fd2610f4 61 fields · synced May 17, 2026
- EUDAMED b175ca27-0a9c-4826-ac2b-5e0e60b53832 61 fields · synced May 17, 2026
- EUDAMED 5152c269-e014-49ed-8803-8bb830ff5a20 61 fields · synced May 17, 2026
- EUDAMED 81cb1989-0139-43d3-973b-f83fc3f7f1a1 61 fields · synced May 18, 2026
- EUDAMED ad48a0a3-7fe5-4df9-8714-f22cefdd0446 61 fields · synced May 18, 2026