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Octabone® Syringe
EUDAMEDClass III (EU MDR)
Ref S01-0210Ref S05-0512Ref S05-0210Ref S25-0210Ref S05-1217Ref S25-1217
Identity
- Trade Name
- Octabone® Syringe EUDAMED
- Device Name
- Octabone® Syringe EUDAMED
- Model / Reference
- S01-0210 EUDAMEDS05-0512 EUDAMEDS05-0210 EUDAMEDS25-0210 EUDAMEDS05-1217 EUDAMEDS25-1217 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490621960 EUDAMED08809490621885 EUDAMED08809490621984 EUDAMED08809490621977 EUDAMED08809490621908 EUDAMED08809490621892 EUDAMED
- Basic UDI-DI
- B-08809490621960 EUDAMEDB-08809490621885 EUDAMEDB-08809490621984 EUDAMEDB-08809490621977 EUDAMEDB-08809490621908 EUDAMEDB-08809490621892 EUDAMED
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Portugal 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
Octabone® 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-08809490621960 | 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 (6)
- EUDAMED 6c6691ab-6ed3-45d3-9bab-7ceab9776c9b 61 fields · synced Sep 17, 2026
- EUDAMED 80a8aced-23eb-414a-a782-cbdc88219c94 61 fields · synced May 17, 2026
- EUDAMED 141aff67-43bf-4213-a630-73adce1effd7 61 fields · synced May 17, 2026
- EUDAMED 15261a55-75c1-4a1f-a210-3ac6101f8d21 61 fields · synced May 17, 2026
- EUDAMED b46df752-0e8f-4d2b-8620-e58a5b91b39f 61 fields · synced May 18, 2026
- EUDAMED 726763b8-10e6-4a23-8ab4-854c460b4cb3 61 fields · synced May 19, 2026