Heltiso TEST COMBO ANTYGENOWY SARS-COV-2/ GRYPA A/GRYPA B+ ADV/ RSV SZYBKI TEST (LFIA)

Name: Heltiso TEST COMBO ANTYGENOWY SARS-COV-2/ GRYPA A/GRYPA B+ ADV/ RSV SZYBKI TEST (LFIA)
Brand: Jiangsu Medomics Medical Technology Co.,Ltd.
SKU: 06974167892188

Unknown / Not in EUDAMED

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 06974167892188Basic UDI-DI 697416789123143ZP

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

Identification

Model: 123143-01-102 123143-02-102 123143-05-102 123143-20-102
EMDN: W0105099099
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)

Related UDI-DIs

Name	UDI-DI	Certificate
Co-Test 5in1 COMBO TEST SARS-CoV-2/Influensa A/B ADV/RSV Antigen	06974167891822	Unknown / Not in EUDAMED Snapshot 2026-10-31 · Link to EUDAMED
DIATHER TEST SARS-CoV-2/Grypa A/Grypa B +ADV/RSV Antygen Combo szybki test (LFIA) do samodzielnego wykonania	06974167891648	Unknown / Not in EUDAMED Snapshot 2026-10-31 · Link to EUDAMED
H&W SARS-CoV-2/ Inﬂuenssa A/B /ADV/RSV antigeeni Combo pikatesti (LFIA)	06974167891631	Unknown / Not in EUDAMED Snapshot 2026-10-31 · Link to EUDAMED
I&A Medical SARS-CoV-2/FluA/FluB+ ADV/RSV Antigen Combo Rapid Test Kit(LFIA)	06974167891846	Unknown / Not in EUDAMED Snapshot 2026-10-31 · Link to EUDAMED
Rapichek SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)	06974167892591	Unknown / Not in EUDAMED Snapshot 2026-10-31 · Link to EUDAMED
SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)	06974167891655	Unknown / Not in EUDAMED Snapshot 2026-10-31 · Link to EUDAMED
SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)	06974167891587	Unknown / Not in EUDAMED Snapshot 2026-10-31 · Link to EUDAMED
SEMA PROTECT TEST SARS-CoV-2/Grypa A/Grypa B +ADV/RSV Antygen Combo szybki test (LFIA)	06974167892492	Unknown / Not in EUDAMED Snapshot 2026-10-31 · Link to EUDAMED
Testera SARS-CoV-2/FluA/ FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)	06974167891778	Unknown / Not in EUDAMED Snapshot 2026-10-31 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/heltiso-test-combo-antygenowy-sars-cov-2-grypa-a-grypa-b-adv-2188 · UDI page: /udi/06974167892188

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