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IH BT Abutment
EUDAMEDClass IIb (EU MDR)
Ref IHBAR2260Model IH IMPLANT SYSTEM Ref IHBAM2240Ref IHBAM2260Ref IHBAM2210
Identity
- Trade Name
- IH BT Abutment EUDAMED
- Device Name
- IH BT Abutment EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDIHBAR2260 EUDAMEDIHBAM2240 EUDAMEDIHBAM2260 EUDAMEDIHBAM2210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041357208 EUDAMED08800041357123 EUDAMED08800041357147 EUDAMED08800041357093 EUDAMED
- Basic UDI-DI
- B-08800041357208 EUDAMEDB-08800041357123 EUDAMEDB-08800041357147 EUDAMEDB-08800041357093 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 BT 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-08800041357208 | 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 53eb3ed8-990d-4bbf-95f3-393aa575d1d1 61 fields · synced Aug 1, 2026
- EUDAMED cb4545ef-5bf1-4506-9c44-4cafa6822ebd 61 fields · synced May 18, 2026
- EUDAMED 005dc51f-3801-4119-93c9-fe0eb288f8c3 61 fields · synced May 19, 2026
- EUDAMED 42da5bd5-6ee0-451c-a617-ccc2e44e5560 61 fields · synced May 19, 2026