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Titan-X
EUDAMEDClass III (EU MDR)
Ref 05-1217Ref 05-0512Ref 20-1217Ref 10-0512Ref 10-1217Ref 01-0210Ref 25-1217
Identity
- Trade Name
- TITAN-X EUDAMED
- Device Name
- TITAN-X EUDAMED
- Model / Reference
- 05-1217 EUDAMED05-0512 EUDAMED20-1217 EUDAMED10-0512 EUDAMED10-1217 EUDAMED01-0210 EUDAMED25-1217 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490622110 EUDAMED08809490622066 EUDAMED08809490622134 EUDAMED08809490622073 EUDAMED08809490622127 EUDAMED08809490621991 EUDAMED08809490622103 EUDAMED
- Basic UDI-DI
- B-08809490622110 EUDAMEDB-08809490622066 EUDAMEDB-08809490622134 EUDAMEDB-08809490622073 EUDAMEDB-08809490622127 EUDAMEDB-08809490621991 EUDAMEDB-08809490622103 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 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-08809490622110 | 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 (7)
- EUDAMED f8362b4b-d2ca-4314-82f3-040943b286be 61 fields · synced Jul 26, 2026
- EUDAMED 93d244a3-fe85-4cbf-8721-3c1d7dadb22f 61 fields · synced May 17, 2026
- EUDAMED 887fe04b-9639-4fd2-a86b-0e05749e715e 61 fields · synced May 17, 2026
- EUDAMED 4ec5fad5-2a31-447c-824d-e30e0e664683 61 fields · synced May 17, 2026
- EUDAMED 6b99444d-1f80-400d-ab69-71c6dd211e2e 61 fields · synced May 17, 2026
- EUDAMED 4cfeb64b-0cf5-4664-a35d-2f7efd37b0db 61 fields · synced May 18, 2026
- EUDAMED 80b30403-154b-46ab-aea5-9d469c613754 61 fields · synced May 19, 2026