Identity
- Trade Name
- Ti Blank Abutment EUDAMED
- Device Name
- Ti Blank Abutment EUDAMED
- Model / Reference
- TBARRN12A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070221532 EUDAMED
- Basic UDI-DI
- B-08800070221532 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ti Blank Abutment by Izenimplant Co., Ltd — Class IIb — 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-08800070221532 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Izenimplant Co., Ltd
- EUDAMED SRN
- KR-MF-000026205
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED f70007d2-214a-459e-bdbe-c43de1aaa7d6 61 fields · synced Sep 18, 2026