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UDI Compass

INTUITY ELITE VALVES

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 07612989037415Basic UDI-DI 0690103D002IEV000TS

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Class III · MDR · Edwards Lifesciences LLC

Identification

Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
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)

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INTUITY ELITE VALVES07612989037392
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INTUITY ELITE VALVES07612989037378
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INTUITY ELITE VALVES07612989037385
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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/intuity-elite-valves-7415 · UDI page: /udi/07612989037415

All devices from Edwards Lifesciences LLC