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i-system Smart Abutment
EUDAMEDClass IIb (EU MDR)
Ref I-SSRA6050(2)Ref I-SSRA5050(2)Ref I-SSRA4050(2)Ref I-SSRA3050(2)Ref I-SSRA1050(2)
by Novodent SA
Identity
- Trade Name
- i-system Smart Abutment EUDAMED
- Device Name
- i-system Smart Abutment EUDAMED
- Model / Reference
- I-SSRA6050(2) EUDAMEDI-SSRA5050(2) EUDAMEDI-SSRA4050(2) EUDAMEDI-SSRA3050(2) EUDAMEDI-SSRA1050(2) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168187767 EUDAMED07640168187750 EUDAMED07640168187743 EUDAMED07640168187736 EUDAMED07640168187712 EUDAMED
- Basic UDI-DI
- B-07640168187767 EUDAMEDB-07640168187750 EUDAMEDB-07640168187743 EUDAMEDB-07640168187736 EUDAMEDB-07640168187712 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 Smart 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-07640168187767 | 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 (5)
- EUDAMED 587eb8ab-cc68-4366-a21c-cc91edf3889c 61 fields · synced Sep 17, 2026
- EUDAMED db616516-a18e-4fc3-b92a-618537ccc615 61 fields · synced May 17, 2026
- EUDAMED a7c30438-8cdf-4104-b675-c4f0fa47c1a0 61 fields · synced May 17, 2026
- EUDAMED d45a0f02-2d47-42ea-a57d-24aafd909e31 61 fields · synced May 18, 2026
- EUDAMED b0998cfe-43a5-4829-894f-77209b26d70f 61 fields · synced May 18, 2026