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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

COVID-19 Antigen Pen Home Test

UDI-DI 06979452730459Basic UDI-DI 697945273A48410HAZ

Class C · IVDR · Azubio Diagnostics Co., Ltd

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

6188356TD02

EU technical documentation assessment · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-08-06 · Expiry 2031-08-01

Scope not stated in certificate data.

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

6188356CE02

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-08-06 · Expiry 2031-01-01

Scope not stated in certificate data.

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

Manufacturer

Azubio Diagnostics Co., Ltd

SRN CN-MF-000032581

CN · Huzhou

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

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/covid-19-antigen-pen-home-test-0459 · UDI page: /udi/06979452730459

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