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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Reveal 35C

UDI-DI 00628011941015Basic UDI-DI 628011941FPD0100Z7

Class IIa · MDR · KA Imaging Inc.

Identification
Model
101
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

28620131494-01

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2022-11-17 · Expiry 2027-08-23

Scope not stated in certificate data.

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

Manufacturer

KA Imaging Inc.

SRN CA-MF-000030642

CA · Waterloo

manufacturer

Authorised representative: Qualrep Services B.V. (NL-AR-000000537)

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/reveal-35c-1015 · UDI page: /udi/00628011941015

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