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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Onepix

UDI-DI 07350118640012Basic UDI-DI 735011864OPXK8

Class IIa · MDR · Unident AB

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

28620145488

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2023-03-23 · Expiry 2027-12-16

Scope not stated in certificate data.

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

Manufacturer

Unident AB

SRN SE-MF-000004887

SE · Falkenberg

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/onepix-0012 · UDI page: /udi/07350118640012

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