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UDI Compass

INTUITY ELITE DELIVERY SYSTEM

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 00690103192575Basic UDI-DI 0690103D002IED000PU

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Class III · MDR · Edwards Lifesciences LLC

Identification

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

Certificates

3828128TD03

EU technical documentation assessment · valid

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

Valid from 2023-05-16 · Expiry 2028-05-16

Scope not stated in certificate data.

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

Manufacturer

Edwards Lifesciences LLC

SRN US-MF-000007139

US · Irvine

manufacturer

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

Related UDI-DIs

NameUDI-DICertificate
INTUITY ELITE DELIVERY SYSTEM00690103192551
Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

INTUITY ELITE DELIVERY SYSTEM00690103192582
Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

INTUITY ELITE DELIVERY SYSTEM00690103192544
Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/intuity-elite-delivery-system-2575 · UDI page: /udi/00690103192575

All devices from Edwards Lifesciences LLC