Identity
- Trade Name
- Ti-oss® EUDAMEDTI-OSS FDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- Ti-oss® EUDAMED
- Model / Reference
- 01-1217 EUDAMED01-0512 EUDAMED25-0210 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809490620406 EUDAMED08809490620253 EUDAMED08809490620116 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809490620406 EUDAMEDB-08809490620253 EUDAMEDB-08809490620116 EUDAMED
- FDA Product Code
- NPM FDA UDI
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
- GMDN Term
- Dental bone matrix implant, animal-derived FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Market of Registration
- Germany EUDAMEDFrance EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ti-oss® by Chiyewon Co., LTD. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809490620406 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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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 70b120a0-5dbf-445e-a24a-f287c0a1aded 61 fields · synced Jul 14, 2026
- EUDAMED fe0a6e96-6527-4b92-a166-8d7993a95e98 61 fields · synced May 18, 2026
- EUDAMED 1eb4f251-c6e4-4ae9-b214-55786e23d6a9 61 fields · synced May 18, 2026
- FDA UDI 0cf2b98a-7c4a-4431-81b3-79c811e26ce1 32 fields · synced May 30, 2026