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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Acmex Treponema Pallidum (TP) Antibody Test

UDI-DI 00628347561093Basic UDI-DI 62834756AL02090279

Class C · IVDR · Artron Laboratories Inc.

Identification
Model
Cassette
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

2026-IVDR/TD-003

EU technical documentation assessment · valid

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

Valid from 2026-05-27 · Expiry 2029-08-06

Scope not stated in certificate data.

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

2026-IVDR/QS-003

EU quality management system · valid

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

Valid from 2026-05-27 · Expiry 2029-08-06

Scope not stated in certificate data.

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

Manufacturer

Artron Laboratories Inc.

SRN CA-MF-000028974

CA · Burnaby, British Columbia

manufacturer

Authorised representative: MedNet EC-REP GmbH (DE-AR-000000002)

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Canonical device page: /device/acmex-treponema-pallidum-tp-antibody-test-1093 · UDI page: /udi/00628347561093

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