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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

SAPIEN M3 Transcatheter Heart Valve

UDI-DI 00690103218107Basic UDI-DI 0690103D003SM3000TP

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

G70 039555 0224

EU technical documentation assessment · unknown

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-06-16 · Expiry 2030-04-10

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

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/sapien-m3-transcatheter-heart-valve-8107 · UDI page: /udi/00690103218107

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