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IH Cement Abutment
EUDAMEDClass IIb (EU MDR)
Ref AIHCARN6535SCModel IH IMPLANT SYSTEM
Identity
- Trade Name
- IH Cement Abutment EUDAMED
- Device Name
- IH Cement Abutment EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDAIHCARN6535SC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041324040 EUDAMED
- Basic UDI-DI
- B-08800041324040 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
The IH Cement Abutment is a Class IIb medical device used for the placement of cement in orthopedic implantable devices. It features sterile construction, a durable design, and a user-friendly interface.
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-08800041324040 | 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 d89989aa-1a4a-47b3-b385-ce2f6f012b4e 61 fields · synced Jul 14, 2026