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Alpha-Bio Tec™ xenobone Syringe
EUDAMEDClass III (EU MDR)
Ref S25-1217Ref S25-0512Ref S05-0512Ref S01-0210
Identity
- Trade Name
- Alpha-Bio Tec™ xenobone Syringe EUDAMED
- Device Name
- Alpha-Bio Tec™ xenobone Syringe EUDAMED
- Model / Reference
- S25-1217 EUDAMEDS25-0512 EUDAMEDS05-0512 EUDAMEDS01-0210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490623230 EUDAMED08809490623216 EUDAMED08809490623223 EUDAMED08809490623186 EUDAMED
- Basic UDI-DI
- B-08809490623230 EUDAMEDB-08809490623216 EUDAMEDB-08809490623223 EUDAMEDB-08809490623186 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 Syringe 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-08809490623230 | 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 0bd92949-0ae8-43d9-8ca0-95494e79d47e 61 fields · synced Jul 12, 2026
- EUDAMED 43695351-bab5-4fde-9648-8a44b9baedf6 61 fields · synced May 17, 2026
- EUDAMED 1c823ba4-8f86-4dc3-b75a-6ba3ef4f6baf 61 fields · synced May 17, 2026
- EUDAMED 560b3c0e-14d7-40f0-a484-14d66f2669b4 61 fields · synced May 18, 2026