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i-system Fixture Analog
EUDAMEDClass I (EU MDR)
Ref I-SFA(2)Ref I-SFA(2.5)Ref I-SFA(3)
by Novodent SA
Identity
- Trade Name
- i-system Fixture Analog EUDAMED
- Device Name
- Bone Level Mini Fixture Lab Analog EUDAMED
- Model / Reference
- I-SFA(2) EUDAMEDI-SFA(2.5) EUDAMEDI-SFA(3) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630188200263 EUDAMED07630188200256 EUDAMED07630188200249 EUDAMED
- Basic UDI-DI
- 764016818003D7 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
i-system Fixture Analog by Novodent SA — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764016818003D7 | Class I | 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 dc27b94b-619a-4513-9597-d28cb4b87aa1 61 fields · synced Jul 20, 2026
- EUDAMED f2276a03-61eb-4d61-9282-1bef0cbae7a6 61 fields · synced May 18, 2026
- EUDAMED eee66efc-b3cb-4b16-bf62-f6c4eef68e0a 61 fields · synced May 18, 2026