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Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

SMARTABLATE Irrigation Tubing Set

UDI-DI 10846835009743Basic UDI-DI 08468350a0005EX

Class IIa · MDR · Biosense Webster, Inc

Identification
Model
SMARTABLATE Irrigation Tubing Set
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

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/smartablate-irrigation-tubing-set-9743 · UDI page: /udi/10846835009743

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