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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Hyaluxelle

UDI-DI 08053689863307Basic UDI-DI 803363895ID0015E

Class III · MDR · IBSA FARMACEUTICI ITALIA SRL

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

EPT 0477.MDR.22/4994.2

EU quality management system · valid

Notified body: Eurofins Product Testing Italy S.r.l. (0477)

Valid from 2025-12-19 · Expiry 2027-06-06

Scope not stated in certificate data.

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

EPT 0477.MDR.22/4993.2

EU technical documentation assessment · valid

Notified body: Eurofins Product Testing Italy S.r.l. (0477)

Valid from 2025-12-19 · Expiry 2027-06-06

Scope not stated in certificate data.

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

Manufacturer

IBSA FARMACEUTICI ITALIA SRL

SRN IT-MF-000008111

IT · lodi

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hyaluxelle-3307 · UDI page: /udi/08053689863307

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