Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

Standard Adult PK 0,7 m2 Hemoconcentrator SET - ETO sterile

UDI-DI 08033772328593Basic UDI-DI 803377232HMC-SET-ETO-Z8

Class IIb · MDR · Medica S.p.A.

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Identification

Model: —
EMDN: C03010101
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR 00048-A

EU quality management system · valid

Notified body: KIWA CERMET ITALIA S.P.A. (0476)

Valid from 2026-04-16 · Expiry 2028-05-31

Scope not stated in certificate data.

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

Manufacturer

SRN IT-MF-000025691

IT · Medolla

manufacturer

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HPH-400TS HEMOCONCENTR 08056992333598
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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/standard-adult-pk-0-7-m2-hemoconcentrator-set-eto-sterile-8593 · UDI page: /udi/08033772328593

All devices from Medica S.p.A.

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