Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Nebulair aerosol (S4-001)

UDI-DI 08054085121282Basic UDI-DI 80540851211NL

Class IIb · MDR · ENABLE INNOVATIONS SRL

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Identification

Model: Soluzione inalatoria S4
EMDN: Q030199
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

Epid aerosol (S4-002) 08054085121312
Epid aerosol (S4-002) 08054085121305
Nebulair aerosol (S4-001) 08054085121299

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/nebulair-aerosol-s4-001-1282 · UDI page: /udi/08054085121282

All devices from ENABLE INNOVATIONS SRL

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