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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

HIV (1+2) Antibody Rapid Test

UDI-DI 06940131405005Basic UDI-DI 69401314HIV002CG

Class D · IVDR · NewScen Coast Bio-Pharmaceutical Co.,Ltd.

Identification
Model
HIV3-29204017000
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

V76 095791 0014

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2025-08-04 · Expiry 2030-08-03

Scope not stated in certificate data.

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

Manufacturer

NewScen Coast Bio-Pharmaceutical Co.,Ltd.

SRN CN-MF-000021934

CN · Tianjin

manufacturer

Authorised representative: Wellkang Ltd (XI-AR-000001836)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hiv-1-2-antibody-rapid-test-5005 · UDI page: /udi/06940131405005

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