No Certificate Found

Snapshot 2026-10-11 · Link to EUDAMED

Legacy device

Sonalleve

UDI-DI 07540281000243Basic UDI-DI B-07540281000243

Class IIb · MDD (legacy) · Profound Medical Inc.

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Identification

Model: SONALLEVE MR-HIFU V2 ACHIEVA 3T
EMDN: Z1204021501
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Manufacturer

Profound Medical Inc.

SRN CA-MF-000028761

CA · Mississauga

manufacturer

Authorised representative: MDSS GmbH (DE-AR-000005430)

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/sonalleve-mr-hifu-v2-achieva-3t-0243 · UDI page: /udi/07540281000243

All devices from Profound Medical Inc.

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