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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Cordella Sensor Delivery Kit (includes Cordella Sensor and Cordella Delivery System)

UDI-DI 00850008997006Basic UDI-DI 0850008997CORDELLAXA

Class III · MDR · Endotronix, Inc.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
Yes
Reusable surgical
No
Certificates

MDR 804297

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-08-03 · Expiry 2030-06-03

Scope not stated in certificate data.

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

Manufacturer

Endotronix, Inc.

SRN US-MF-000043257

US · Naperville, Illinois

manufacturer

Authorised representative: Edwards Lifesciences GmbH (DE-AR-000006184)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/cordella-sensor-delivery-kit-includes-cordella-sensor-and-co-7006 · UDI page: /udi/00850008997006

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