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Cemented Abutment + Abutment Screw
EUDAMEDClass IIb (EU MDR)
Ref CARRN70205SRef CARRN60307SRef CARRN50305S
Identity
- Trade Name
- Cemented Abutment + Abutment Screw EUDAMED
- Device Name
- Cemented Abutment + Abutment Screw EUDAMED
- Model / Reference
- CARRN70205S EUDAMEDCARRN60307S EUDAMEDCARRN50305S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070213643 EUDAMED08800070213612 EUDAMED08800070213490 EUDAMED
- Basic UDI-DI
- B-08800070213643 EUDAMEDB-08800070213612 EUDAMEDB-08800070213490 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
Cemented 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-08800070213643 | 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 (3)
- EUDAMED c34b05d8-b62d-4ea8-971d-949ca34e9294 61 fields · synced Sep 18, 2026
- EUDAMED 26bc1bd3-d685-4463-8373-00003e1fcb0d 61 fields · synced May 18, 2026
- EUDAMED 4fcac670-2ed1-42ea-ae5c-3b049a8e5138 61 fields · synced May 19, 2026