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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

COVID-19/ Flu A&B Ag Rapid Test

UDI-DI 06974849368901Basic UDI-DI 697484936HWTS-RT200A59

Class C · IVDR · Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Identification
Model
HWTS-RT200A
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

EU-TDA-FI-92654-800162-2026

EU technical documentation assessment · valid

Notified body: Kiwa Sertio Oy (3018)

Valid from 2026-07-09 · Expiry 2031-07-09

Scope not stated in certificate data.

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

Manufacturer

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

SRN CN-MF-000012807

CN · Nantong City, Jiangsu

manufacturer

Authorised representative: Medunion S.L. (ES-AR-000019366)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/covid-19-flu-a-b-ag-rapid-test-8901 · UDI page: /udi/06974849368901

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