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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Acmex Hepatitis B Surface Antigen (HBsAg) Test

UDI-DI 00628347560928Basic UDI-DI 62834756AL0201025Z

Class D · IVDR · Artron Laboratories Inc.

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

2024-IVDR/TD-005/B

EU technical documentation assessment · unknown

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

Valid from 2026-01-27 · Expiry 2029-08-06

Scope not stated in certificate data.

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

2024-IVDR/QS-005/B

EU quality management system · unknown

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

Valid from 2026-01-27 · 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)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/acmex-hepatitis-b-surface-antigen-hbsag-test-0928 · UDI page: /udi/00628347560928

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