Identity
- Trade Name
- IMACTIS Navigation station EUDAMED
- Device Name
- IMACTIS® Navigation Station EUDAMED
- Model / Reference
- J02000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B681J0200000 EUDAMED
- Basic UDI-DI
- ++B6816000EMSW5 EUDAMED
- Direct Marketing DI
- +B681J0200000 EUDAMED
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
IMACTIS Navigation station by Imactis Sas — Class IIb — 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 | ++B6816000EMSW5 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Imactis Sas
- EUDAMED SRN
- FR-MF-000004452
Sources (1)
- EUDAMED 38fa639f-6d9e-4cb0-b595-8bb106d220ca 61 fields · synced Jun 19, 2026