Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

Gelclair

UDI-DI 08055960290420Basic UDI-DI 805596029051FF

Class IIa · MDR · Biokosmes s.r.l.

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Identification

Model: 0BIO4I02ED03
EMDN: M9002
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

EPT 0477.MDR.24/5443

EU quality management system · valid

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

Valid from 2024-04-12 · Expiry 2029-04-11

Scope not stated in certificate data.

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

Manufacturer

Biokosmes s.r.l.

SRN IT-MF-000017206

IT · Bosisio Parini

manufacturer

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/gelclair-0420 · UDI page: /udi/08055960290420

All devices from Biokosmes s.r.l.

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