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IH Abutment Screw
EUDAMEDClass IIb (EU MDR)
Ref IHASD128Model IH IMPLANT SYSTEM Ref OTASR200Ref OTASM200
Identity
- Trade Name
- IH Abutment Screw EUDAMED
- Device Name
- IH Abutment Screw EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDIHASD128 EUDAMEDOTASR200 EUDAMEDOTASM200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041351268 EUDAMED08800041351282 EUDAMED08800041351275 EUDAMED
- Basic UDI-DI
- B-08800041351268 EUDAMEDB-08800041351282 EUDAMEDB-08800041351275 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 Abutment Screw 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-08800041351268 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED b87a7c23-5145-4bdb-af57-33dd65a7e353 61 fields · synced Jul 29, 2026
- EUDAMED 5888c69b-a691-4ed8-8cd6-47eeee41af10 61 fields · synced May 17, 2026
- EUDAMED 430ccbd8-0a1f-407c-8e07-b6ea8a1f0b89 61 fields · synced May 18, 2026