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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Sky CI™ L90 Sound Processor

UDI-DI 00197420006948Basic UDI-DI 08400944CI5298YQ

Class III · MDR · Advanced Bionics LLC

Identification
Model
—
EMDN
J0380
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

G70 077725 0043

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-09-02 · Expiry 2031-09-01

Scope not stated in certificate data.

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

Manufacturer

Advanced Bionics LLC

SRN US-MF-000019344

US · Valencia

manufacturer

Authorised representative: Advanced Bionics Logistic Services GmbH (DE-AR-000056289)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/sky-citm-l90-sound-processor-6948 · UDI page: /udi/00197420006948

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