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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

ColoMaia II

UDI-DI 08594225430015Basic UDI-DI 859422543ColoMaiaIINK

Class IIa · MDR · MAIA LABS s.r.o.

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

2026-MDR/QS-027

EU quality management system · valid

Notified body: 3EC International a.s. (2265)

Valid from 2026-05-25 · Expiry 2031-05-25

Scope not stated in certificate data.

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

Manufacturer

MAIA LABS s.r.o.

SRN CZ-MF-000044767

CZ · Brno

manufacturer

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/colomaia-ii-0015 · UDI page: /udi/08594225430015

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