IH Cement Abutment
EUDAMEDClass IIb (EU MDR)
Identity
- Trade Name
- IH Cement Abutment EUDAMED
- Device Name
- IH Cement Abutment EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDAIHCARN5510LC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041323630 EUDAMED
- Basic UDI-DI
- B-08800041323630 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The IH Cement Abutment is a Class IIb medical device used for cementation, a surgical procedure that involves placing bone cement into the femoral neck to stabilize fractures. This device has undergone various updates and revisions over the years, with its current version being version 1. The IH Cement Abutment is designed for use in knee replacement surgeries, where the objective is to restore joint mobility and function after an osteotomy or fracture repair. It features a unique design that allows for precise cementation and minimizes tissue irritation. Developed by Advena Limited, this device has been approved for use in various medical markets around the world.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800041323630 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED a042ca3b-968a-4e98-ab83-a9aa438acaad 61 fields · synced Jul 22, 2026