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TEST COMBO 8w1 SARS-CoV-2/ Grypa A/ Grypa B/ RSV/ ADV/ PIV/ HRV/ MPV Szybki test do samokontroli metodą (LFIA)

Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

UDI-DI 06974167892270Basic UDI-DI 697416789123145ZT

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Class C · IVDR · Jiangsu Medomics Medical Technology Co.,Ltd.

Identification

Model
123145-01-102 123145-02-102 123145-05-102 123145-20-102
Issuing agency
GS1
Device status
active
Sterile
No

Certificates

EU-TDA-FI-06912-800035-2025-1

EU technical documentation assessment · unknown

Notified body: Kiwa Sertio Oy (3018)

Valid from 2026-09-10 · Expiry 2030-01-31

Scope not stated in certificate data.

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

Manufacturer

Jiangsu Medomics Medical Technology Co.,Ltd.

SRN CN-MF-000030226

CN · Nanjing

manufacturer

Authorised representative: Mega Eurostar Sp. z o.o. (PL-AR-000042730)

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HELTISO TEST COMBO ANTYGENOWY 8 w 1 SARS-CoV-2/ Grypa A/ Grypa B/ RSV/ ADV/ PIV/ HRV/ MPV Szybki test do samokontroli metodą LFIA06974167892638
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H&W Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)06974167892393
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I&A medical Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)06974167892911
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JOYTEST Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)06974167892515
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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/test-combo-8w1-sars-cov-2-grypa-a-grypa-b-rsv-adv-piv-hrv-mp-2270 · UDI page: /udi/06974167892270

All devices from Jiangsu Medomics Medical Technology Co.,Ltd.