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Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

ColdZyme

UDI-DI 07340031105040Basic UDI-DI 73400311CZMSJE

Class III · MDR · Enzymatica AB

Identification
Model
—
EMDN
V9017
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

EPT 0477.MDR.24/5406

EU quality management system · valid

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

Valid from 2024-03-07 · Expiry 2029-03-06

Scope not stated in certificate data.

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

EPT 0477.MDR.24/5405

EU technical documentation assessment · valid

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

Valid from 2024-03-07 · Expiry 2029-03-06

Scope not stated in certificate data.

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

Manufacturer

Enzymatica AB

SRN SE-MF-000002254

SE · Lund

manufacturer

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Canonical device page: /device/coldzyme-5040 · UDI page: /udi/07340031105040

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