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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-28 · Link to EUDAMED

Edwards EVOQUE

UDI-DI 00690103219081Basic UDI-DI 0690103D004EVV000Z3

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

3828128TD05

EU technical documentation assessment · unknown

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

Valid from 2025-07-08 · Expiry 2028-10-13

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

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/edwards-evoque-9081 · UDI page: /udi/00690103219081

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