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TITAN-X Syringe
EUDAMEDClass III (EU MDR)
Ref S25-1217Ref S25-0210Ref S01-0210Ref S25-0512Ref S05-0512
Identity
- Trade Name
- TITAN-X Syringe EUDAMED
- Device Name
- TITAN-X Syringe EUDAMED
- Model / Reference
- S25-1217 EUDAMEDS25-0210 EUDAMEDS01-0210 EUDAMEDS25-0512 EUDAMEDS05-0512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490622233 EUDAMED08809490622196 EUDAMED08809490622189 EUDAMED08809490622219 EUDAMED08809490622226 EUDAMED
- Basic UDI-DI
- B-08809490622233 EUDAMEDB-08809490622196 EUDAMEDB-08809490622189 EUDAMEDB-08809490622219 EUDAMEDB-08809490622226 EUDAMED
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Czechia 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
TITAN-X 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-08809490622233 | 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 (5)
- EUDAMED 5a577bef-d4aa-48b4-87a1-57d679e96770 61 fields · synced Aug 1, 2026
- EUDAMED 3ec6dfe9-8913-495e-b6a2-54fc7c5c9538 61 fields · synced May 17, 2026
- EUDAMED b3077d51-ae0f-4128-9024-d21f8c77ea44 61 fields · synced May 18, 2026
- EUDAMED 8b724257-beb3-4b88-9f73-f36a5c43dd40 61 fields · synced May 18, 2026
- EUDAMED e114577e-db6a-4c00-af90-985ee8b48a2b 61 fields · synced May 19, 2026