Identity
- Trade Name
- TITAN-X Syringe EUDAMEDTITAN-X Block EUDAMED
- Device Name
- TITAN-X Block EUDAMED
- Model / Reference
- BLK8825 EUDAMEDBLK8812 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490622172 EUDAMED
- Basic UDI-DI
- B-08809490622172 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-08809490622172 | 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 (2)
- EUDAMED c24341e3-bbe5-4c57-9fbb-9039b06191ec 61 fields · synced Jun 17, 2026
- EUDAMED b4a29208-6221-4099-93be-1e18084a41d2 61 fields · synced Jun 11, 2026