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i-system Miling Abutment
EUDAMEDClass IIb (EU MDR)
Ref I-SMIA1050(2)Ref I-SMIA6050(2)Ref I-SMIA3050(2)
by Novodent SA
Identity
- Trade Name
- i-system Miling Abutment EUDAMED
- Device Name
- i-system Miling Abutment EUDAMED
- Model / Reference
- I-SMIA1050(2) EUDAMEDI-SMIA6050(2) EUDAMEDI-SMIA3050(2) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168187774 EUDAMED07640168187828 EUDAMED07640168187798 EUDAMED
- Basic UDI-DI
- B-07640168187774 EUDAMEDB-07640168187828 EUDAMEDB-07640168187798 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 Miling 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-07640168187774 | 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 (3)
- EUDAMED 1e07e843-4a66-4277-ac7a-83c25913458a 61 fields · synced Jul 30, 2026
- EUDAMED f26bb049-d4a5-421c-9854-7cb674396364 61 fields · synced May 18, 2026
- EUDAMED f36bbb1c-d7bd-4722-9126-e79df2a86a3d 61 fields · synced May 18, 2026