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Ti-oss® Syringe
EUDAMEDFDA UDIClass III (EU MDR)
Ref S01-0210Ref S25-0512Ref S05-0210
Identity
- Trade Name
- Ti-oss® Syringe EUDAMEDTI-OSS FDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- Ti-oss® Syringe EUDAMED
- Model / Reference
- S01-0210 EUDAMEDS25-0512 EUDAMEDFDA UDIS05-0210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490621939 EUDAMED08809490620499 EUDAMEDFDA UDI08809490621953 EUDAMED
- Basic UDI-DI
- B-08809490621939 EUDAMEDB-08809490620499 EUDAMEDB-08809490621953 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 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® Syringe 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-08809490621939 | 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 94bf3633-be33-4322-822f-be0e4fca7140 61 fields · synced Jul 29, 2026
- EUDAMED 9bb7afc2-41c1-4ac0-bd2e-2027ca858f9d 61 fields · synced May 17, 2026
- EUDAMED 09463f0d-c394-4061-9515-9748f48a9fd2 61 fields · synced May 19, 2026
- FDA UDI 93300123-90a1-4a82-b232-de592553b2c6 32 fields · synced May 30, 2026