CeCert/086/W/E.1

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IVDD Annex III Section 6·Shenzhen Zijian Biotechnology Co., Ltd·CeCert Sp. z o.o.·2 Basic UDI-DIs

CeCert/126/W/E.1

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IVDD Annex III Section 6·Shenzhen Huian Biosci Technology Co., Ltd.·CeCert Sp. z o.o.·6 Basic UDI-DIs

CeCert/057/W/E.1

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IVDD Annex III Section 6·Zhongshan Bio-Tech Co., Ltd.·CeCert Sp. z o.o.·2 Basic UDI-DIs

CeCert/036/W/E.1

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

CeCert/037/W/E.1

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IVDD Annex III Section 6·Merlin Biomedical (Xiamen) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

OD-OS GmbH

Importer

🇩🇪 Germany·1 Manufacturer

Clinical Consulting Sp. z o.o.

Authorized representative

🇵🇱 Poland·1 Manufacturer

Neomed Polska Sp. z o.o.

Authorized representative

🇵🇱 Poland

Valentis Polska Spółka z o.o.

Authorized representative

🇵🇱 Poland·1 Manufacturer

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Authorized representative

🇵🇱 Poland·3 Manufacturers·224 Devices

EU-TDA-FI-06912-800035-2025-1

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IVDR Technical Documentation·Jiangsu Medomics Medical Technology Co.,Ltd.·Sertio Oy·1 Basic UDI-DI

5903769501717

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MDD Annex V·Gofarm Sp. z o.o. Sp. k.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

1434-MDD-434/2020

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MDD Annex V·Gofarm Sp. z o.o. Sp. k.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·4 Basic UDI-DIs

1434-MDD-377/2020

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MDD Annex V·Gofarm Sp. z o.o. Sp. k.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

1434-MDD-184/2020

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MDD Annex V·Gofarm Sp. z o.o. Sp. k.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-MDD-195/2020

Certificate

MDD Annex V·Gofarm Sp. z o.o. Sp. k.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs

1434-MDD-200/2020

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MDD Annex V·Gofarm Sp. z o.o. Sp. k.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-MDD-331/2020

Certificate

MDD Annex V·Gofarm Sp. z o.o. Sp. k.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·8 Basic UDI-DIs

1434-MDD-461/2020

Certificate

MDD Annex V·Gofarm Sp. z o.o. Sp. k.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·8 Basic UDI-DIs

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MDR Technical Documentation·Aflofarm Farmacja Polska Sp. z o.o.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI