Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)

Name: Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)
Brand: BioTeke Corporation（Wuxi）Co., Ltd
SKU: 06974541564458

UDI-DI 06974541564458Basic UDI-DI 697454156017LA

Class C · IVDR · BioTeke Corporation（Wuxi）Co., Ltd

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Identification

Model: ICA2114-7
EMDN: W0105099099
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

EU-TDA-FI-43117-800031-2025

EU technical documentation assessment · valid

Notified body: Kiwa Sertio Oy (3018)

Valid from 2025-05-30 · Expiry 2030-05-30

Scope not stated in certificate data.

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

Manufacturer

BioTeke Corporation（Wuxi）Co., Ltd

SRN CN-MF-000007517

CN · Wuxi

manufacturer

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

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Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay) 06974541564434
Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay) 06974541564465

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/multiple-respiratory-multipathogen-antigen-test-kit-immunoch-4458 · UDI page: /udi/06974541564458

All devices from BioTeke Corporation（Wuxi）Co., Ltd

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