COVID-19 & Influenza A/B Antigen Nasal Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

CeCert/077/W/E.1

Certificate

IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

HX 2074650-1

Certificate

IVDR QMS·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH

HL 2074650-1

Certificate

IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

2020-IVD/DE-006/A

Certificate

IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·3EC International a.s.·1 Basic UDI-DI

CeCert/081/W/E.4

Certificate

IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

1434-IVDD-078/2022

Certificate

IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

244409553-200

Certificate

IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

HL 202746520-1

Certificate

IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

HL 202746520-1

Certificate

IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

mdi Europa GmbH

Authorized representative

🇩🇪 Germany·132 Manufacturers·4741 Devices

SH MEDICAL SALUD Y SERVICIOS IBERICA S.L.

Importer

🇪🇸 Spain

International Emergency Services, S.L. (IES MEDICAL®)

Importer

🇪🇸 Spain

Technomedics Norge AS

Importer

🇳🇴 Norway·12 Manufacturers

NOVAINTERMED SRL

Importer

🇷🇴 Romania·14 Manufacturers

S. A. B. Impex, s.r.o.

Importer

🇨🇿 Czechia·18 Manufacturers

Hofmeester Dental B.V.

Importer

🇳🇱 Netherlands·16 Manufacturers

C2KA001

Basic UDI-DI

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·1 device

C2KA003

Basic UDI-DI

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·1 device

C2KA002

Basic UDI-DI

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·1 device