Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

COVID-19 /Flu A &B/ RSV/ADV Ag Combo Rapid Test

UDI-DI 06974849368871Basic UDI-DI 697484936W01050703VD

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

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Identification

Model: HWTS-RT065A
EMDN: W0105090699
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

COVID-19 /Flu A &B/ RSV/ADV Ag Combo Rapid Test 06974849368888
COVID-19 /Flu A &B/ RSV/ADV Ag Combo Rapid Test 06974849368857
COVID-19 /Flu A &B/ RSV/ADV Ag Combo Rapid Test 06974849368864

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/covid-19-flu-a-b-rsv-adv-ag-combo-rapid-test-8871 · UDI page: /udi/06974849368871

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

Scan an inventory CSV