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IH Temporary Abutment
EUDAMEDClass IIb (EU MDR)
Ref AIHTARN4510Model IH IMPLANT SYSTEM Ref AIHTARH4510DRef IHTARN4530Ref IHTARN4510
Identity
- Trade Name
- IH Temporary Abutment EUDAMED
- Device Name
- IH Temporary Abutment EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDAIHTARN4510 EUDAMEDAIHTARH4510D EUDAMEDIHTARN4530 EUDAMEDIHTARN4510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041350698 EUDAMED08800041350339 EUDAMED08800041350193 EUDAMED08800041350155 EUDAMED
- Basic UDI-DI
- B-08800041350698 EUDAMEDB-08800041350339 EUDAMEDB-08800041350193 EUDAMEDB-08800041350155 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
IH Temporary Abutment by SEWONMEDIX Inc. — 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-08800041350698 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (4)
- EUDAMED 9d238812-5a9a-4a75-b299-98701102efea 61 fields · synced Aug 2, 2026
- EUDAMED 6f375772-65ec-485c-955b-c049837daa8b 61 fields · synced May 18, 2026
- EUDAMED 7331bce3-29b6-4d2d-bc59-ee06ff4f326a 61 fields · synced May 18, 2026
- EUDAMED ee85a620-74fc-4496-8f9a-6d8c2accd05d 61 fields · synced May 19, 2026