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IH FreeMilling Abutment
EUDAMEDClass IIb (EU MDR)
Ref AIHFMRH5520Model IH IMPLANT SYSTEM Ref AIHFMRN6010Ref AIHFMRH6030Ref AIHFMRN4530Ref AIHFMRN5020Ref AIHFMMN4520Ref AIHFMRN6020Ref AIHFMRN6520Ref AIHFMRH5530Ref AIHFMRN6030Ref AIHFMRN5510Ref AIHFMRH5010DRef AIHFMRH4530DRef AIHFMRH4520DRef AIHFMRH6530Ref AIHFMRH4510DRef AIHFMRN5030Ref AIHFMRH5030DRef AIHFMRH5020Ref AIHFMRN6530Ref AIHFMRH6020Ref AIHFMRN5010Ref AIHFMRN4520Ref AIHFMRN5530Ref AIHFMRH6520
Identity
- Trade Name
- IH FreeMilling Abutment EUDAMED
- Device Name
- IH FreeMilling Abutment EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDAIHFMRH5520 EUDAMEDAIHFMRN6010 EUDAMEDAIHFMRH6030 EUDAMEDAIHFMRN4530 EUDAMEDAIHFMRN5020 EUDAMEDAIHFMMN4520 EUDAMEDAIHFMRN6020 EUDAMEDAIHFMRN6520 EUDAMEDAIHFMRH5530 EUDAMEDAIHFMRN6030 EUDAMEDAIHFMRN5510 EUDAMEDAIHFMRH5010D EUDAMEDAIHFMRH4530D EUDAMEDAIHFMRH4520D EUDAMEDAIHFMRH6530 EUDAMEDAIHFMRH4510D EUDAMEDAIHFMRN5030 EUDAMEDAIHFMRH5030D EUDAMEDAIHFMRH5020 EUDAMEDAIHFMRN6530 EUDAMEDAIHFMRH6020 EUDAMEDAIHFMRN5010 EUDAMEDAIHFMRN4520 EUDAMEDAIHFMRN5530 EUDAMEDAIHFMRH6520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041348893 EUDAMED08800041349241 EUDAMED08800041348930 EUDAMED08800041349173 EUDAMED08800041349197 EUDAMED08800041349135 EUDAMED08800041349258 EUDAMED08800041349289 EUDAMED08800041348909 EUDAMED08800041349265 EUDAMED08800041349210 EUDAMED08800041349005 EUDAMED08800041348992 EUDAMED08800041348985 EUDAMED08800041348961 EUDAMED08800041348978 EUDAMED08800041349203 EUDAMED08800041349029 EUDAMED08800041348862 EUDAMED08800041349296 EUDAMED08800041348923 EUDAMED08800041349180 EUDAMED08800041349166 EUDAMED08800041349234 EUDAMED08800041348954 EUDAMED
- Basic UDI-DI
- B-08800041348893 EUDAMEDB-08800041349241 EUDAMEDB-08800041348930 EUDAMEDB-08800041349173 EUDAMEDB-08800041349197 EUDAMEDB-08800041349135 EUDAMEDB-08800041349258 EUDAMEDB-08800041349289 EUDAMEDB-08800041348909 EUDAMEDB-08800041349265 EUDAMEDB-08800041349210 EUDAMEDB-08800041349005 EUDAMEDB-08800041348992 EUDAMEDB-08800041348985 EUDAMEDB-08800041348961 EUDAMEDB-08800041348978 EUDAMEDB-08800041349203 EUDAMEDB-08800041349029 EUDAMEDB-08800041348862 EUDAMEDB-08800041349296 EUDAMEDB-08800041348923 EUDAMEDB-08800041349180 EUDAMEDB-08800041349166 EUDAMEDB-08800041349234 EUDAMEDB-08800041348954 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa 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 FreeMilling 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-08800041348893 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (25)
- EUDAMED 165f287e-1fc2-4ab6-9d76-64b8df284eea 61 fields · synced Aug 3, 2026
- EUDAMED 16c7ee78-f764-445c-b2e8-1584eacbdfea 61 fields · synced May 11, 2026
- EUDAMED 253b0088-66c9-452d-9524-59ad82389fa2 61 fields · synced May 16, 2026
- EUDAMED 66ce470a-d651-4a72-a791-1a6d6dd4f31d 61 fields · synced May 16, 2026
- EUDAMED ec02147c-e3e2-4a35-9608-875c359fc47d 61 fields · synced May 16, 2026
- EUDAMED 89db6d23-f781-4be7-bbfc-c845f4f58c4d 61 fields · synced May 16, 2026
- EUDAMED 5a5f63aa-5d9d-45d9-acc0-3f89e6e693bb 61 fields · synced May 16, 2026
- EUDAMED b2523c29-481d-4b97-9880-be8bd1cbfaf0 61 fields · synced May 16, 2026
- EUDAMED 4b3f4542-2864-4066-8c63-89070cd75416 61 fields · synced May 17, 2026
- EUDAMED 444da5d8-46f5-4b70-b4d4-b691c8658abb 61 fields · synced May 17, 2026
- EUDAMED 971fb518-4673-418b-96f8-44605d4b4390 61 fields · synced May 17, 2026
- EUDAMED fccc37f2-f792-43c9-80f2-67e591da8524 61 fields · synced May 17, 2026
- EUDAMED de9fc0e9-4706-4504-87c6-a50d4d74bb88 61 fields · synced May 17, 2026
- EUDAMED d50e4ef5-ec78-4833-878b-b212c2fa2c46 61 fields · synced May 17, 2026
- EUDAMED 3467158c-9ad9-43d6-bb35-e979542c2cc2 61 fields · synced May 17, 2026
- EUDAMED 79049e96-637f-4493-ba63-7cc7da3e676d 61 fields · synced May 17, 2026
- EUDAMED ac7303f9-42d8-4ec7-aad8-00af2d89ec53 61 fields · synced May 17, 2026
- EUDAMED 653930c4-555e-4f9f-b951-a0c9e26c84ea 61 fields · synced May 17, 2026
- EUDAMED 551ec82a-14be-4fc9-b781-b0523480c4dc 61 fields · synced May 18, 2026
- EUDAMED 3992ca39-8d3a-4305-b353-d446287a72de 61 fields · synced May 18, 2026
- EUDAMED 17a85a84-9d2c-44c2-b24d-2311434c4f25 61 fields · synced May 18, 2026
- EUDAMED 39c26956-d0c3-4bd5-88e5-d410719a8591 61 fields · synced May 18, 2026
- EUDAMED df0e0f9f-852b-4ea0-a54d-a5f4f330b531 61 fields · synced May 18, 2026
- EUDAMED 6922c597-1985-40b6-8d7c-629bd2bbaf41 61 fields · synced May 19, 2026
- EUDAMED 1047377a-63d9-4ed3-aae7-d0f339d53511 61 fields · synced May 19, 2026