Identity
- Trade Name
- iCONNECT CARTO System Cable EUDAMED
- Device Name
- iCONNECT CARTO Connection Cable EUDAMED
- Model / Reference
- 001-009075-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M58800100907510 EUDAMED
- Basic UDI-DI
- ++M588001009075MT EUDAMED
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Category: Neurological stereotactic surgery system
iCONNECT CARTO System Cable by Stereotaxis, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++M588001009075MT | Class I | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
- EUDAMED SRN
- US-MF-000026621
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 01de4cb4-b8c3-429e-a33c-4980ab82ff05 61 fields · synced Jul 29, 2026