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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Evoke® External Closed-Loop Stimulator (eCLS)

UDI-DI 09352307001398Basic UDI-DI 935230701020AN

Class III · MDR · Saluda Medical Pty Ltd

Identification
Model
1020
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

MDR 776672

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-09-04 · Expiry 2029-04-08

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Saluda Medical Pty Ltd

SRN AU-MF-000010522

AU · Macquarie Park

manufacturer

Authorised representative: MedR-AR Services B.V. (NL-AR-000000120)

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/evoke-external-closed-loop-stimulator-ecls-1398 · UDI page: /udi/09352307001398

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