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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

FLUIStar A (S1-001)

UDI-DI 08054085121725Basic UDI-DI 80540851208NX

Class IIb · MDR · ENABLE INNOVATIONS SRL

Identification
Model
Soluzione inalatoria S1
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

0425-MDR-030179-00

EU quality management system · valid

Notified body: ICIM S.P.A. (0425)

Valid from 2026-03-23 · Expiry 2031-03-22

Scope not stated in certificate data.

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

Manufacturer

ENABLE INNOVATIONS SRL

SRN IT-MF-000026066

IT · CARPI (MO)

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/fluistar-a-s1-001-1725 · UDI page: /udi/08054085121725

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