Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

SMARTABLATE System Interface Cable

UDI-DI 10846835012644Basic UDI-DI 08468350a0003ET

Class Is · MDR · Biosense Webster, Inc

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Identification

Model: SMARTABLATE System Interface Cable Stockert and CARTO XP Interface Cables CARTO 3 System Interface Cables Interface Cables CARTO 3 SYSTEM eco Interface Cable TX eco EXT Cable Interface Cables for Multi-Electrode Ablation Catheter and CELSIUS Catheter
EMDN: Z12059080
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

3903009CE01

EU quality management system · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-09-01 · Expiry 2031-09-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Biosense Webster, Inc

SRN US-MF-000014219

US · Irvine, California

manufacturer

Authorised representative: Biosense Webster A Division of Johnson & Johnson Medical NV/SA (BE-AR-000012231)

Related UDI-DIs

CARTO 3 System eco Interface Cable 10846835009712
CARTO 3 System eco Interface Cable 10846835022056
CARTO 3 System Interface Cable 10846835003796
CARTO 3 System Interface Cable 10846835003789
CARTO 3 System Interface Cable 10846835003857
CARTO 3 System Interface Cable 10846835003871
CARTO 3 System Interface Cable 10846835003826
CARTO 3 System Interface Cable 10846835012576
CARTO 3 System Interface Cable 10846835003918
CARTO 3 System Interface Cable 10846835003802
CARTO 3 System Interface Cable 10846835003925
INTERFACE CABLE 10846835010121

Showing 12 of 22 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/smartablate-system-interface-cable-2644 · UDI page: /udi/10846835012644

All devices from Biosense Webster, Inc

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