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Ti Blank Abutment ( Ti Blank Abutment + Abutment Screw)
EUDAMEDClass IIb (EU MDR)
Ref TBASRH14MSRef TBASRN12MSRef TBASRN14ASRef TBASRN10ASRef TBASRN14MSRef TBASRH10ASRef TBASRH12MSRef TBASRN12AS
Identity
- Device Name
- Ti Blank Abutment ( Ti Blank Abutment + Abutment Screw) EUDAMED
- Model / Reference
- TBASRH14MS EUDAMEDTBASRN12MS EUDAMEDTBASRN14AS EUDAMEDTBASRN10AS EUDAMEDTBASRN14MS EUDAMEDTBASRH10AS EUDAMEDTBASRH12MS EUDAMEDTBASRN12AS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070221631 EUDAMED08800070221686 EUDAMED08800070221662 EUDAMED08800070221648 EUDAMED08800070221693 EUDAMED08800070221587 EUDAMED08800070221624 EUDAMED08800070221655 EUDAMED
- Basic UDI-DI
- B-08800070221631 EUDAMEDB-08800070221686 EUDAMEDB-08800070221662 EUDAMEDB-08800070221648 EUDAMEDB-08800070221693 EUDAMEDB-08800070221587 EUDAMEDB-08800070221624 EUDAMEDB-08800070221655 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 ( Ti Blank Abutment + Abutment Screw) 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-08800070221631 | 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 (8)
- EUDAMED 36f11bae-9565-4b7c-85cd-8a5f35b1e9bd 61 fields · synced Sep 18, 2026
- EUDAMED ae26775d-3ce5-4ddf-9100-348e237b0692 61 fields · synced May 16, 2026
- EUDAMED 583f628d-ea82-4865-925d-7a5b3227fe40 61 fields · synced May 17, 2026
- EUDAMED f649a9ff-38a3-4740-98f2-04b756ab3e73 61 fields · synced May 18, 2026
- EUDAMED cbd3b009-5bfb-454a-ad43-cea7d72c48fd 61 fields · synced May 18, 2026
- EUDAMED eb5cb5a5-7546-4aed-b2ca-dbf3dc91a796 61 fields · synced Jul 10, 2026
- EUDAMED 61a6985a-d590-4417-91d8-a973f6f5f347 61 fields · synced Jul 11, 2026
- EUDAMED cf88a3b6-dec9-4e24-a916-aca7f5bcc405 61 fields · synced Jul 16, 2026