Identity
- Trade Name
- i-system Implant Surgical Kit EUDAMED
- Device Name
- i-system Implant Surgical Kit EUDAMED
- Model / Reference
- I-SSK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630188200232 EUDAMED
- Basic UDI-DI
- 763018820SSKMV EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- A dental implant surgical kit is specifically designed for the placement of dental implants, which are used to replace missing teeth. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
i-system Implant Surgical Kit 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 | 763018820SSKMV | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novodent Sa
- EUDAMED SRN
- CH-PR-000042189
Sources (1)
- EUDAMED 27d68e44-a74e-4b49-b266-8fbb6cb7b72a 61 fields · synced Jun 19, 2026