Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）

Basic UDI-DI

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

SARS-CoV-2 Antigen Rapid Test Cassette

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·1 device

Covid-19 Antigen CARD Kit

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Fosun Diagnostics (Shanghai) Co., Ltd.·1 device

Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Daan Gene Co., Ltd.·1 device

Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Daan Gene Co., Ltd.·1 device

EUROBYTECH

Importer

🇫🇷 France·5 Manufacturers

1434-MDR-010/2024

Certificate

MDR QMS·MIM Fertility Sp. z o.o.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

TNP/MDR/003/0139/2022

Certificate

MDR QMS·FAMED ŻYWIEC SP. Z O.O.·TUV NORD Polska Sp. z o.o

HD 1967019-1

Certificate

MDD Annex II (excluding section 4)·APD-Medical Sp. z o.o.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

DD 60147392 0001

Certificate

MDD Annex V·OPTOPOL Technology Sp. z o.o.·TÜV Rheinland LGA Products GmbH·4 Basic UDI-DIs

1434-MDD-578/2019

Certificate

MDD Annex II (excluding section 4)·AIR PRODUCTS SP z o.o.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

DD 601485730001

Certificate

MDD Annex V·Messer Polska Sp. z o.o.·TÜV Rheinland LGA Products GmbH·10 Basic UDI-DIs

TNP/MDD/0365/4114/2021

Certificate

MDD Annex II (excluding section 4)·Bowil Biotech sp. z o.o.·TUV NORD Polska Sp. z o.o·6 Basic UDI-DIs

TNP/MDD/0365/4114/2021

Certificate

MDD Annex II (excluding section 4)·Bowil Biotech sp. z o.o.·TUV NORD Polska Sp. z o.o·17 Basic UDI-DIs

1434-MDD-587/2019

Certificate

MDD Annex II Section 4·Celther Polska Sp. z o.o.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·4 Basic UDI-DIs

DD601473920001

Certificate

MDD Annex V·OPTOPOL Technology Sp. z o.o.·TÜV Rheinland LGA Products GmbH·4 Basic UDI-DIs

S.C. DENTAL EQUIPMENT STORE S.R.L

Importer

🇷🇴 Romania·5 Manufacturers

CeCert/068/W/E.2

Certificate

IVDD Annex III Section 6·Hangzhou Laihe Biotech Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

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

CeCert/115/W/E.1

Certificate

IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI