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i-system Healing Abutment
EUDAMEDClass IIb (EU MDR)
Ref I-SHA6040(2)Ref I-SHA3050(2)Ref I-SHA4040(2.5)Ref I-SHA2040(2.5)Ref I-SHA3050(2.5)Ref I-SHA6050(3)Ref I-SHA2065(3)Ref I-SHA6065(3)Ref I-SHA2050(2.5)Ref I-SHA1040(2.5)Ref I-SHA4050(2)Ref I-SHA3065(3)Ref I-SHA3040(2)Ref I-SHA4050(2.5)Ref I-SHA6050(2.5)Ref I-SHA1040(2)Ref I-SHA5050(2.5)Ref I-SHA5050(2)Ref I-SHA1050(2)Ref I-SHA4040(2)Ref I-SHA5040(2.5)Ref I-SHA3040(2.5)Ref I-SHA5040(2)Ref I-SHA2050(3)Ref I-SHA2040(2)
by Novodent SA
Identity
- Trade Name
- i-system Healing Abutment EUDAMED
- Device Name
- i-system Healing Abutment EUDAMED
- Model / Reference
- I-SHA6040(2) EUDAMEDI-SHA3050(2) EUDAMEDI-SHA4040(2.5) EUDAMEDI-SHA2040(2.5) EUDAMEDI-SHA3050(2.5) EUDAMEDI-SHA6050(3) EUDAMEDI-SHA2065(3) EUDAMEDI-SHA6065(3) EUDAMEDI-SHA2050(2.5) EUDAMEDI-SHA1040(2.5) EUDAMEDI-SHA4050(2) EUDAMEDI-SHA3065(3) EUDAMEDI-SHA3040(2) EUDAMEDI-SHA4050(2.5) EUDAMEDI-SHA6050(2.5) EUDAMEDI-SHA1040(2) EUDAMEDI-SHA5050(2.5) EUDAMEDI-SHA5050(2) EUDAMEDI-SHA1050(2) EUDAMEDI-SHA4040(2) EUDAMEDI-SHA5040(2.5) EUDAMEDI-SHA3040(2.5) EUDAMEDI-SHA5040(2) EUDAMEDI-SHA2050(3) EUDAMEDI-SHA2040(2) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168186449 EUDAMED07640168186395 EUDAMED07640168186524 EUDAMED07640168186487 EUDAMED07640168186517 EUDAMED07640168186685 EUDAMED07640168186616 EUDAMED07640168186692 EUDAMED07640168186494 EUDAMED07640168186463 EUDAMED07640168186418 EUDAMED07640168186630 EUDAMED07640168186388 EUDAMED07640168186531 EUDAMED07640168186579 EUDAMED07640168186340 EUDAMED07640168186555 EUDAMED07640168186432 EUDAMED07640168186357 EUDAMED07640168186401 EUDAMED07640168186548 EUDAMED07640168186500 EUDAMED07640168186425 EUDAMED07640168186609 EUDAMED07640168186364 EUDAMED
- Basic UDI-DI
- B-07640168186449 EUDAMEDB-07640168186395 EUDAMEDB-07640168186524 EUDAMEDB-07640168186487 EUDAMEDB-07640168186517 EUDAMEDB-07640168186685 EUDAMEDB-07640168186616 EUDAMEDB-07640168186692 EUDAMEDB-07640168186494 EUDAMEDB-07640168186463 EUDAMEDB-07640168186418 EUDAMEDB-07640168186630 EUDAMEDB-07640168186388 EUDAMEDB-07640168186531 EUDAMEDB-07640168186579 EUDAMEDB-07640168186340 EUDAMEDB-07640168186555 EUDAMEDB-07640168186432 EUDAMEDB-07640168186357 EUDAMEDB-07640168186401 EUDAMEDB-07640168186548 EUDAMEDB-07640168186500 EUDAMEDB-07640168186425 EUDAMEDB-07640168186609 EUDAMEDB-07640168186364 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
i-system Healing Abutment by Novodent SA — 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-07640168186449 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (25)
- EUDAMED 993a3f6d-1471-4607-85c9-ad3ecf1b0f07 61 fields · synced Jul 31, 2026
- EUDAMED 3d89ff9c-bee2-4d56-8ba7-eef91ebad2e9 61 fields · synced May 16, 2026
- EUDAMED 9c7acdd1-0054-4f41-949e-335e19c39c8c 61 fields · synced May 16, 2026
- EUDAMED d9ae5e93-8cc4-4787-9614-26519715f58b 61 fields · synced May 16, 2026
- EUDAMED ea13c082-520b-449e-8765-5e395734e7be 61 fields · synced May 17, 2026
- EUDAMED b849f307-364d-4182-bb80-8aea49dfdd5a 61 fields · synced May 17, 2026
- EUDAMED d04a9084-5e80-4f82-97c5-0e1c8625e430 61 fields · synced May 17, 2026
- EUDAMED 58f38ccb-c43a-4eeb-87a1-c3787bec0b7e 61 fields · synced May 17, 2026
- EUDAMED e61e31ed-09ee-434b-beb8-4cf2d57ececb 61 fields · synced May 17, 2026
- EUDAMED 2f5c4886-cee7-4e6e-9de4-3adae5a66921 61 fields · synced May 17, 2026
- EUDAMED 4e5cbab9-deca-470e-994d-a7275fcae0d6 61 fields · synced May 17, 2026
- EUDAMED 8022e801-2be2-4de0-ba5c-17e4755a0d88 61 fields · synced May 17, 2026
- EUDAMED cd460bf2-0736-4160-8bc9-974832279b75 61 fields · synced May 18, 2026
- EUDAMED e78d70e2-a1f5-43f6-9161-a70734fa4f7f 61 fields · synced May 18, 2026
- EUDAMED 49fec9cb-ab5c-430e-b6aa-481f5f3c7ccf 61 fields · synced May 18, 2026
- EUDAMED c885bba1-3cc7-4b93-bb49-14070149c856 61 fields · synced May 18, 2026
- EUDAMED 4cd5cc09-f12d-4263-968b-71acbd49ba04 61 fields · synced May 18, 2026
- EUDAMED 4a00271d-e3c7-4922-ae20-48afbb4658e5 61 fields · synced May 18, 2026
- EUDAMED 8984bed7-1214-43a6-9f4f-b9a822cc077f 61 fields · synced May 18, 2026
- EUDAMED 647c2a02-3759-4b15-ac72-e16828556743 61 fields · synced May 18, 2026
- EUDAMED 5bca8384-332d-4155-aeff-22f81e2ab443 61 fields · synced May 18, 2026
- EUDAMED 105f05ad-145f-4fe9-acbe-3548e00eb10c 61 fields · synced May 18, 2026
- EUDAMED f18aa532-9e1c-480a-b202-f90008fc1cc1 61 fields · synced May 19, 2026
- EUDAMED 48263998-c876-4c3e-a41e-989208ac9e53 61 fields · synced May 19, 2026
- EUDAMED 4b80026e-d87a-4638-a258-7c06df2b63f9 61 fields · synced May 19, 2026