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IMACTIS® NaviKit™
EUDAMEDClass IIa (EU MDR)
Ref I10100Model NaviKit™
by Imactis Sas
Identity
- Trade Name
- IMACTIS® NaviKit™ EUDAMED
- Device Name
- NaviKit EUDAMED
- Model / Reference
- NaviKit™ EUDAMEDI10100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B681I101002 EUDAMED
- Basic UDI-DI
- ++B6816001KITWY EUDAMED
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- A single use navigation kit IMACTIS® NaviKit™ used for one medical procedure, including a sterile adhesive dressing, a sterile needle holder, a sterile cable fixation system and a sterile cover system; EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
IMACTIS® NaviKit™ by Imactis Sas — Class IIa — 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 | ++B6816001KITWY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Imactis Sas
- EUDAMED SRN
- FR-PR-000004453
Sources (1)
- EUDAMED bbe79bba-3370-46c1-950a-b9220b99ade2 61 fields · synced Jun 18, 2026