HELTISO TEST COMBO ANTYGENOWY 8 w 1 SARS-CoV-2/ Grypa A/ Grypa B/ RSV/ ADV/ PIV/ HRV/ MPV Szybki test do samokontroli metodą LFIA

Name: HELTISO TEST COMBO ANTYGENOWY 8 w 1 SARS-CoV-2/ Grypa A/ Grypa B/ RSV/ ADV/ PIV/ HRV/ MPV Szybki test do samokontroli metodą LFIA
Brand: Jiangsu Medomics Medical Technology Co.,Ltd.
SKU: 06974167892638

Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

UDI-DI 06974167892638Basic UDI-DI 697416789123145ZT

Scan an inventory CSV

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

Identification

Model: 123145-01-102 123145-02-102 123145-05-102 123145-20-102
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)

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Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)	06974167892263	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)	06974167892171	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)	06974167892157	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)	06974167892881	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
H&W Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)	06974167892393	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
I&A medical Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)	06974167892911	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
JOYTEST Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)	06974167892515	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
Mila8 TEST Combo	06974167892478	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED
TEST COMBO 8w1 SARS-CoV-2/ Grypa A/ Grypa B/ RSV/ ADV/ PIV/ HRV/ MPV Szybki test do samokontroli metodą (LFIA)	06974167892270	Unknown / Not in EUDAMED Snapshot 2026-11-02 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/heltiso-test-combo-antygenowy-8-w-1-sars-cov-2-grypa-a-grypa-2638 · UDI page: /udi/06974167892638

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