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UDI Compass

PASCAL

Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 00690103213324Basic UDI-DI 0690103S004PAS000BC

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Class III · MDR · Edwards Lifesciences LLC

Identification

Model
—
EMDN
P0799
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No

Certificates

3828128TD02

EU technical documentation assessment · unknown

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

Valid from 2023-04-13 · Expiry 2027-08-04

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
PASCAL00690103213331
Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

PASCAL00690103213317
Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/pascal-3324 · UDI page: /udi/00690103213324

All devices from Edwards Lifesciences LLC