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IH LT Abutment
EUDAMEDClass IIb (EU MDR)
Ref AIHLAM3550Model IH IMPLANT SYSTEMRef AIHLAM3560Ref AIHLAM3510Ref AIHLAR4050Ref AIHLAM3540Ref AIHLAM3570Ref AIHLAR4030Ref AIHLAR4010
Identity
- Trade Name
- IH LT Abutment EUDAMED
- Device Name
- IH LT Abutment EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDAIHLAM3550 EUDAMEDAIHLAM3560 EUDAMEDAIHLAM3510 EUDAMEDAIHLAR4050 EUDAMEDAIHLAM3540 EUDAMEDAIHLAM3570 EUDAMEDAIHLAR4030 EUDAMEDAIHLAR4010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041367511 EUDAMED08800041367528 EUDAMED08800041367474 EUDAMED08800041367580 EUDAMED08800041367504 EUDAMED08800041367535 EUDAMED08800041367566 EUDAMED08800041367542 EUDAMED
- Basic UDI-DI
- B-08800041367511 EUDAMEDB-08800041367528 EUDAMEDB-08800041367474 EUDAMEDB-08800041367580 EUDAMEDB-08800041367504 EUDAMEDB-08800041367535 EUDAMEDB-08800041367566 EUDAMEDB-08800041367542 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 LT 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-08800041367511 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (8)
- EUDAMED de9ea816-56ff-462f-b7de-200d0b608735 61 fields · synced Jul 28, 2026
- EUDAMED 88849835-475e-4d62-a4a7-5688b1eb359d 61 fields · synced May 16, 2026
- EUDAMED a0152a75-1c65-4691-a379-1df9285c488e 61 fields · synced May 17, 2026
- EUDAMED d18ed1e5-3748-4136-8872-036057ffaeb6 61 fields · synced May 18, 2026
- EUDAMED b1d5135f-647c-4969-b9d0-3e0370b3b4a8 61 fields · synced May 18, 2026
- EUDAMED f458b6de-3250-42e1-b0b4-a94816cad5d3 61 fields · synced May 18, 2026
- EUDAMED b7363766-1d58-4dde-a984-66053f59e054 61 fields · synced May 19, 2026
- EUDAMED 6cf9dcce-8acd-4ae7-9547-f0fe5a8815aa 61 fields · synced May 19, 2026